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CompletedNCT03252249Updated Nov 3, 2026Results posted

Duration of Dual Anti-Platelet Therapy (DUAL-ACS)

A Phase 4 interventional study of 3 months dual anti-platelet therapy and 12 months dual anti-platelet therapy in Acute Coronary Syndrome and Coronary Artery Disease, sponsored by University of Edinburgh. Completed at 49 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by University of Edinburgh · Phase 4, Interventional, and Treatment

Updated Nov 3, 2026First site in New ZealandStart date moved+1 moreGo to Updates ↓

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Phase
Phase 4
Study type
Interventional
Enrollment
5,094
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 93 studies in Acute Coronary Syndrome with a site in United Kingdom — 9 open to participants now, 12 under way, none of them phase 3. Acute Coronary Syndrome · United Kingdom.

Enrollment
17th of 64
5,094 · median 1,202
Started
2018
with 5 others
Phase 4
13 of 93
1 open now
Registered
62nd of 93
by date
Lead sponsor
8 of 93
University of Edinburgh

Among the 93 studies in Acute Coronary Syndrome with a site in United Kingdom, this one is the 17th largest by enrollment of the 64 interventional ones that give a count, is one of 6 that started in 2018, is one of 13 in phase 4, and was the 62nd registered.

Acute Coronary Syndrome

1,489 studies on the registry are indexed under Acute Coronary Syndrome; 271 are open to participants now.

Browse Acute Coronary Syndrome studies →

Open to participants now

9 of the 93 studies in Acute Coronary Syndrome with a site in United Kingdom are open now. Recruiting first, the newest first:

4 more — sign in →

All 9 open studies →

A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →

Who these studies take

Of the 195 Acute Coronary Syndrome studies recruiting now, 144 (74%) set no upper age limit and 19 (10%) stop at 75 or younger; 14 take children under 18; 15 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 93 studies in Acute Coronary Syndrome with a site in United Kingdom, or all of them as a file.
02

Study summary

Despite substantial evidence supporting the use of dual anti-platelet therapy in patients with acute coronary syndrome, there remains major uncertainty regarding the optimal duration of therapy. Recent evidence suggests that shorter durations of dual anti-platelet therapy are superior because the avoidance of atherothrombotic events is counterbalanced by the greater risks of excess major bleeding with apparent increases in all-cause mortality with longer durations. We here propose an international randomised controlled trial of 18,318 patients with type 1 myocardial infarction allocated to differing durations of dual anti-platelet therapy. We will use electronic health record linkage to track duration of therapy and clinical outcomes in a real-world, real-time, efficient and highly cost-effective trial. This has the potential to define treatment duration, settle a major outstanding international controversy, and influence modern cardiology practice across the world.

03

Conditions studied

  • Acute Coronary Syndrome
  • Coronary Artery Disease
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Aged ≥18 years
  • Clinical diagnosis of Type 1 myocardial infarction within 12 weeks
  • In the opinion of the attending clinician requires dual anti- therapy with aspirin and a P2Y12 receptor antagonist
  • Resident in the country of recruitment with their unique health identifier
  • The attending clinician has equipoise regarding the duration of therapy
  • Provision of

Exclusion criteria

Exclusion Criteria:

  • Clear indication for specific duration of dual anti- therapy
  • Type 2 myocardial infarction
  • to aspirin or P2Y12 receptor antagonist
  • Non-resident in the country of recruitment
  • Previous recruitment into the trial
  • Inability or unwilling to give
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
5,094 participants (actual)

Study arms

  • Active comparator
    3 months dual anti-platelet therapy

    3 months dual anti-platelet therapy.

    Other: 3 months dual anti-platelet therapy

  • Active comparator
    12 months dual anti-platelet therapy

    12 months dual anti-platelet therapy.

    Other: 12 months dual anti-platelet therapy

Interventions

  • Other3 months dual anti-platelet therapy

    Patients with acute coronary syndrome will be randomised to 3 months dual anti-platelet therapy.

  • Other12 months dual anti-platelet therapy

    Patients with acute coronary syndrome will be randomised to 12 months dual anti-platelet therapy.

06

What researchers measure

Primary outcomes

  1. Time-to-event: All-cause Mortality

    Restricted Mean Survival Time

    Time frame: Date of index MI to 15 months

  2. Incidence: All-cause Mortality

    Occurrence of event

    Time frame: Date of index MI to 15 months

Secondary outcomes

  1. Time-to-event: Non-cardiovascular Death (Including Fatal Bleeding) and Major Non-fatal Bleeding

    Restricted Mean Survival Time

    Time frame: Date of MI to 15 months

  2. Incidence: Non-cardiovascular Death (Including Fatal Bleeding) and Major Non-fatal Bleeding

    Occurrence of event

    Time frame: Date of MI to 15 months

  3. Time-to-event: Non-cardiovascular Death (Including Fatal Bleeding)

    Restricted Mean Survival Time

    Time frame: Date of MI to 15 months

  4. Incidence: Non-cardiovascular Death (Including Fatal Bleeding)

    Occurrence of event

    Time frame: Date of MI to 15 months

  5. Time-to-event: Major Fatal and Non-fatal Bleeding

    Restricted Mean Survival Time

    Time frame: Date of MI to 15 months

  6. Incidence: Major Fatal and Non-fatal Bleeding

    Occurrence of event

    Time frame: Date of MI to 15 months

  7. Time-to-event: Gastrointestinal Bleeding

    Restricted Mean Survival Time

    Time frame: Date of MI to 15 months

  8. Incidence: Gastrointestinal Bleeding

    Occurrence of event

    Time frame: Date of MI to 15 months

  9. Time-to-event: Cardiovascular Death and Non-fatal Myocardial Infarction

    Restricted Mean Survival Time

    Time frame: Date of MI to 15 months

  10. Incidence: Cardiovascular Death and Non-fatal Myocardial Infarction

    Occurrence of event

    Time frame: Date of MI to 15 months

  11. Time-to-event: Cardiovascular Mortality (Cardiac and Non-cardiac)

    Restricted Mean Survival Time

    Time frame: Date of MI to 15 months

  12. Incidence: Cardiovascular Mortality (Cardiac and Non-cardiac)

    Occurrence of event

    Time frame: Date of MI to 15 months

  13. Time-to-event: Myocardial Infarction (Fatal and Non-fatal)

    Restricted Mean Survival Time

    Time frame: Date of MI to 15 months

  14. Incidence: Myocardial Infarction (Fatal and Non-fatal)

    Occurrence of event

    Time frame: Date of MI to 15 months

  15. Incidence: Intracranial Haemorrhage

    Occurrence of event

    Time frame: Date of MI to 15 months

  16. Time-to-event: Coronary Revascularisation

    Restricted Mean Survival Time

    Time frame: Date of MI to 15 months

  17. Incidence: Coronary Revascularisation

    Occurrence of event

    Time frame: Date of MI to 15 months

  18. Time-to-event: Stent Thrombosis

    Restricted Mean Survival Time

    Time frame: Date of MI to 15 months

  19. Incidence: Stent Thrombosis

    Occurrence of event

    Time frame: Date of MI to 15 months

  20. Time-to-event: Thrombotic Stroke

    Restricted Mean Survival Time

    Time frame: Date of MI to 15 months

  21. Incidence: Thrombotic Stroke

    Occurrence of event

    Time frame: Date of MI to 15 months

Other outcomes

  1. Time-to-event: Iron Therapy

    Restricted Mean Survival Time

    Time frame: Date of MI to 15 months

  2. Incidence: Iron Therapy

    Occurrence of event

    Time frame: Date of MI to 15 months

  3. Time-to-event: Blood Transfusion

    Restricted Mean Survival Time

    Time frame: Date of MI to 15 months

  4. Incidence: Blood Transfusion

    Occurrence of event

    Time frame: Date of MI to 15 months

07

Results

Posted Jan 28, 2026
Limitations and caveats
The major limitation is that early trial termination meant the target sample size was not achieved, leaving an underpowered trial which was unable to address its primary endpoint. The recruitment suspension due to COVID-19, and the subsequent delays in re-opening of the study sites and lack of staff capacity significantly affected recruitment.

Participant flow

All randomised participants in database.

Participant flow — Overall Study
Milestone3 Months Dual Anti-platelet Therapy12 Months Dual Anti-platelet Therapy
Started25262526
Completed25262526
Not completed00

Outcome measures

PrimaryTime-to-event: All-cause Mortality

Restricted Mean Survival Time

Time frame:
Date of index MI to 15 months
Reported as:
Mean · days
Time-to-event: All-cause Mortality
days3 Months Dual Anti-platelet Therapy12 Months Dual Anti-platelet Therapy
Time-to-event: All-cause Mortality447.337 ± 1.0542445.196 ± 1.1741
PrimaryIncidence: All-cause Mortality

Occurrence of event

Time frame:
Date of index MI to 15 months
Reported as:
Count of participants · Participants
Incidence: All-cause Mortality
Participants3 Months Dual Anti-platelet Therapy12 Months Dual Anti-platelet Therapy
Incidence: All-cause Mortality6887
Statistical analysis
  • 3 Months Dual Anti-platelet Therapy vs 12 Months Dual Anti-platelet Therapy · Regression, Cox · p = 0.1232 · Hazard ratio (hr): 0.78 · 95% CI 0.57 to 1.073 versus 12 months (the comparator).
SecondaryTime-to-event: Non-cardiovascular Death (Including Fatal Bleeding) and Major Non-fatal Bleeding

Restricted Mean Survival Time

Time frame:
Date of MI to 15 months
Reported as:
Mean · days
Time-to-event: Non-cardiovascular Death (Including Fatal Bleeding) and Major Non-fatal Bleeding
days3 Months Dual Anti-platelet Therapy12 Months Dual Anti-platelet Therapy
Time-to-event: Non-cardiovascular Death (Including Fatal Bleeding) and Major Non-fatal Bleeding442.881 ± 1.2908440.736 ± 1.3565
SecondaryIncidence: Non-cardiovascular Death (Including Fatal Bleeding) and Major Non-fatal Bleeding

Occurrence of event

Time frame:
Date of MI to 15 months
Reported as:
Number · participants
Incidence: Non-cardiovascular Death (Including Fatal Bleeding) and Major Non-fatal Bleeding
participants3 Months Dual Anti-platelet Therapy12 Months Dual Anti-platelet Therapy
Incidence: Non-cardiovascular Death (Including Fatal Bleeding) and Major Non-fatal Bleeding104127
Statistical analysis
  • 12 Months Dual Anti-platelet Therapy · Regression, Cox · p = 0.1220 · Hazard ratio (hr): 0.82 · 95% CI 0.63 to 1.06
SecondaryTime-to-event: Non-cardiovascular Death (Including Fatal Bleeding)

Restricted Mean Survival Time

Time frame:
Date of MI to 15 months
Reported as:
Mean · days
Time-to-event: Non-cardiovascular Death (Including Fatal Bleeding)
days3 Months Dual Anti-platelet Therapy12 Months Dual Anti-platelet Therapy
Time-to-event: Non-cardiovascular Death (Including Fatal Bleeding)452.453 ± 0.5873452.593 ± 0.5285
SecondaryIncidence: Non-cardiovascular Death (Including Fatal Bleeding)

Occurrence of event

Time frame:
Date of MI to 15 months
Reported as:
Number · participants
Incidence: Non-cardiovascular Death (Including Fatal Bleeding)
participants3 Months Dual Anti-platelet Therapy12 Months Dual Anti-platelet Therapy
Incidence: Non-cardiovascular Death (Including Fatal Bleeding)2729
Statistical analysis
  • 12 Months Dual Anti-platelet Therapy · Regression, Cox · p = 0.7789 · Hazard ratio (hr): 0.93 · 95% CI 0.55 to 1.57
SecondaryTime-to-event: Major Fatal and Non-fatal Bleeding

Restricted Mean Survival Time

Time frame:
Date of MI to 15 months
Reported as:
Mean · days
Time-to-event: Major Fatal and Non-fatal Bleeding
days3 Months Dual Anti-platelet Therapy12 Months Dual Anti-platelet Therapy
Time-to-event: Major Fatal and Non-fatal Bleeding445.227 ± 1.1719442.790 ± 1.2794
SecondaryIncidence: Major Fatal and Non-fatal Bleeding

Occurrence of event

Time frame:
Date of MI to 15 months
Reported as:
Number · participants
Incidence: Major Fatal and Non-fatal Bleeding
participants3 Months Dual Anti-platelet Therapy12 Months Dual Anti-platelet Therapy
Incidence: Major Fatal and Non-fatal Bleeding80102
Statistical analysis
  • 12 Months Dual Anti-platelet Therapy · Regression, Cox · p = 0.0977 · Hazard ratio (hr): 0.78 · 95% CI 0.58 to 1.05
SecondaryTime-to-event: Gastrointestinal Bleeding

Restricted Mean Survival Time

Time frame:
Date of MI to 15 months
Reported as:
Mean · days
Time-to-event: Gastrointestinal Bleeding
days3 Months Dual Anti-platelet Therapy12 Months Dual Anti-platelet Therapy
Time-to-event: Gastrointestinal Bleeding449.967 ± 0.8887450.562 ± 0.7774
SecondaryIncidence: Gastrointestinal Bleeding

Occurrence of event

Time frame:
Date of MI to 15 months
Reported as:
Count of participants · Participants
Incidence: Gastrointestinal Bleeding
Participants3 Months Dual Anti-platelet Therapy12 Months Dual Anti-platelet Therapy
Incidence: Gastrointestinal Bleeding3638
Statistical analysis
  • 12 Months Dual Anti-platelet Therapy · Regression, Cox · p = 0.8208 · Hazard ratio (hr): 0.95 · 95% CI 0.60 to 1.50
SecondaryTime-to-event: Cardiovascular Death and Non-fatal Myocardial Infarction

Restricted Mean Survival Time

Time frame:
Date of MI to 15 months
Reported as:
Mean · days
Time-to-event: Cardiovascular Death and Non-fatal Myocardial Infarction
days3 Months Dual Anti-platelet Therapy12 Months Dual Anti-platelet Therapy
Time-to-event: Cardiovascular Death and Non-fatal Myocardial Infarction422.876 ± 2.1559424.670 ± 2.1010
SecondaryIncidence: Cardiovascular Death and Non-fatal Myocardial Infarction

Occurrence of event

Time frame:
Date of MI to 15 months
Reported as:
Count of participants · Participants
Incidence: Cardiovascular Death and Non-fatal Myocardial Infarction
Participants3 Months Dual Anti-platelet Therapy12 Months Dual Anti-platelet Therapy
Incidence: Cardiovascular Death and Non-fatal Myocardial Infarction236226
Statistical analysis
  • 12 Months Dual Anti-platelet Therapy · Regression, Cox · p = 0.6158 · Hazard ratio (hr): 1.05 · 95% CI 0.87 to 1.26
SecondaryTime-to-event: Cardiovascular Mortality (Cardiac and Non-cardiac)

Restricted Mean Survival Time

Time frame:
Date of MI to 15 months
Reported as:
Mean · days
Time-to-event: Cardiovascular Mortality (Cardiac and Non-cardiac)
days3 Months Dual Anti-platelet Therapy12 Months Dual Anti-platelet Therapy
Time-to-event: Cardiovascular Mortality (Cardiac and Non-cardiac)449.943 ± 0.8891447.897 ± 1.0372
SecondaryIncidence: Cardiovascular Mortality (Cardiac and Non-cardiac)

Occurrence of event

Time frame:
Date of MI to 15 months
Reported as:
Count of participants · Participants
Incidence: Cardiovascular Mortality (Cardiac and Non-cardiac)
Participants3 Months Dual Anti-platelet Therapy12 Months Dual Anti-platelet Therapy
Incidence: Cardiovascular Mortality (Cardiac and Non-cardiac)4056
Statistical analysis
  • 12 Months Dual Anti-platelet Therapy · Regression, Cox · p = 0.1020 · Hazard ratio (hr): 0.71 · 95% CI 0.48 to 1.07
SecondaryTime-to-event: Myocardial Infarction (Fatal and Non-fatal)

Restricted Mean Survival Time

Time frame:
Date of MI to 15 months
Reported as:
Mean · days
Time-to-event: Myocardial Infarction (Fatal and Non-fatal)
days3 Months Dual Anti-platelet Therapy12 Months Dual Anti-platelet Therapy
Time-to-event: Myocardial Infarction (Fatal and Non-fatal)424.471 ± 2.1157427.444 ± 2.0181
SecondaryIncidence: Myocardial Infarction (Fatal and Non-fatal)

Occurrence of event

Time frame:
Date of MI to 15 months
Reported as:
Count of participants · Participants
Incidence: Myocardial Infarction (Fatal and Non-fatal)
Participants3 Months Dual Anti-platelet Therapy12 Months Dual Anti-platelet Therapy
Incidence: Myocardial Infarction (Fatal and Non-fatal)221203
Statistical analysis
  • 12 Months Dual Anti-platelet Therapy · Regression, Cox · p = 0.3623 · Hazard ratio (hr): 1.09 · 95% CI 0.90 to 1.32
SecondaryIncidence: Intracranial Haemorrhage

Occurrence of event

Time frame:
Date of MI to 15 months
Reported as:
Count of participants · Participants
Incidence: Intracranial Haemorrhage
Participants3 Months Dual Anti-platelet Therapy12 Months Dual Anti-platelet Therapy
Incidence: Intracranial Haemorrhage010
SecondaryTime-to-event: Coronary Revascularisation

Restricted Mean Survival Time

Time frame:
Date of MI to 15 months
Reported as:
Mean · days
Time-to-event: Coronary Revascularisation
days3 Months Dual Anti-platelet Therapy12 Months Dual Anti-platelet Therapy
Time-to-event: Coronary Revascularisation414.488 ± 2.3733417.081 ± 2.3383
SecondaryIncidence: Coronary Revascularisation

Occurrence of event

Time frame:
Date of MI to 15 months
Reported as:
Count of participants · Participants
Incidence: Coronary Revascularisation
Participants3 Months Dual Anti-platelet Therapy12 Months Dual Anti-platelet Therapy
Incidence: Coronary Revascularisation286259
Statistical analysis
  • 12 Months Dual Anti-platelet Therapy · Regression, Cox · p = 0.2324 · Hazard ratio (hr): 1.11 · 95% CI 0.94 to 1.31
SecondaryTime-to-event: Stent Thrombosis

Restricted Mean Survival Time

Time frame:
Date of MI to 15 months
Reported as:
Mean · days
Time-to-event: Stent Thrombosis
days3 Months Dual Anti-platelet Therapy12 Months Dual Anti-platelet Therapy
Time-to-event: Stent Thrombosis450.566 ± 0.8329450.026 ± 0.9228
SecondaryIncidence: Stent Thrombosis

Occurrence of event

Time frame:
Date of MI to 15 months
Reported as:
Count of participants · Participants
Incidence: Stent Thrombosis
Participants3 Months Dual Anti-platelet Therapy12 Months Dual Anti-platelet Therapy
Incidence: Stent Thrombosis3432
Statistical analysis
  • 12 Months Dual Anti-platelet Therapy · Regression, Cox · p = 0.8104 · Hazard ratio (hr): 1.06 · 95% CI 0.66 to 1.72
SecondaryTime-to-event: Thrombotic Stroke

Restricted Mean Survival Time

Time frame:
Date of MI to 15 months
Reported as:
Mean · days
Time-to-event: Thrombotic Stroke
days3 Months Dual Anti-platelet Therapy12 Months Dual Anti-platelet Therapy
Time-to-event: Thrombotic Stroke453.711 ± 0.4353454.244 ± 0.3519
SecondaryIncidence: Thrombotic Stroke

Occurrence of event

Time frame:
Date of MI to 15 months
Reported as:
Count of participants · Participants
Incidence: Thrombotic Stroke
Participants3 Months Dual Anti-platelet Therapy12 Months Dual Anti-platelet Therapy
Incidence: Thrombotic Stroke137
Statistical analysis
  • 12 Months Dual Anti-platelet Therapy · Regression, Cox · p = 0.1875 · Hazard ratio (hr): 1.86 · 95% CI 0.74 to 4.65
Other pre-specifiedTime-to-event: Iron Therapy

Restricted Mean Survival Time

Time frame:
Date of MI to 15 months
Reported as:
Mean · days
Time-to-event: Iron Therapy
days3 Months Dual Anti-platelet Therapy12 Months Dual Anti-platelet Therapy
Time-to-event: Iron Therapy439.175 ± 1.5407439.749 ± 1.4840
Other pre-specifiedIncidence: Iron Therapy

Occurrence of event

Time frame:
Date of MI to 15 months
Reported as:
Count of participants · Participants
Incidence: Iron Therapy
Participants3 Months Dual Anti-platelet Therapy12 Months Dual Anti-platelet Therapy
Incidence: Iron Therapy116122
Statistical analysis
  • 12 Months Dual Anti-platelet Therapy · Regression, Cox · p = 0.7220 · Hazard ratio (hr): 0.96 · 95% CI 0.74 to 1.23
Other pre-specifiedTime-to-event: Blood Transfusion

Restricted Mean Survival Time

Time frame:
Date of MI to 15 months
Reported as:
Mean · days
Time-to-event: Blood Transfusion
days3 Months Dual Anti-platelet Therapy12 Months Dual Anti-platelet Therapy
Time-to-event: Blood Transfusion430.118 ± 2.1292430.346 ± 2.1049
Other pre-specifiedIncidence: Blood Transfusion

Occurrence of event

Time frame:
Date of MI to 15 months
Reported as:
Count of participants · Participants
Incidence: Blood Transfusion
Participants3 Months Dual Anti-platelet Therapy12 Months Dual Anti-platelet Therapy
Incidence: Blood Transfusion138140
Statistical analysis
  • 12 Months Dual Anti-platelet Therapy · Regression, Cox · p = 0.8851 · Hazard ratio (hr): 1.017 · 95% CI 0.804 to 1.287

Adverse events

Collected over 15 months from date of randomisation.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
3 Months Dual Anti-platelet Therapy68/2,526 (2.7%)0/2,526 (0%)0/2,526 (0%)
12 Months Dual Anti-platelet Therapy87/2,526 (3.4%)0/2,526 (0%)0/2,526 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)3 Months Dual Anti-platelet Therapy12 Months Dual Anti-platelet TherapyTotal
Mean63.4 ± 10.963.4 ± 10.863.4 ± 10.8
Sex/Gender, Customized
Sex/Gender, Customized(Participants)3 Months Dual Anti-platelet Therapy12 Months Dual Anti-platelet TherapyTotal
Sex; Female, Male — Female6846851369
Sex; Female, Male — Male183818373675
Sex; Female, Male — Not available448
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)3 Months Dual Anti-platelet Therapy12 Months Dual Anti-platelet TherapyTotal
White285284569
Mixed123
Asian121830
Black213
Other729
Not stated or not known5054104
Missing516
Data not collected for Scotland or New Zealand216421644328
Region of Enrollment
Region of Enrollment(participants)3 Months Dual Anti-platelet Therapy12 Months Dual Anti-platelet TherapyTotal
United Kingdom226522694534
New Zealand261257518
Social Deprivation
Social Deprivation(Participants)3 Months Dual Anti-platelet Therapy12 Months Dual Anti-platelet TherapyTotal
Quintile 1 (most deprived)455393848
Quintile 2484511995
Quintile 35054991004
Quintile 4467489956
Quintile 5 (least deprived)447473920
Not recorded154145299
Missing141630
Clinical Management at Randomisation
Clinical Management at Randomisation(Participants)3 Months Dual Anti-platelet Therapy12 Months Dual Anti-platelet TherapyTotal
CABG surgery8180161
Drug eluting stent136413662730
Bare metal stent131427
Medical management169164333
Conservative6967136
ICA planned8308351665
08

Study locations

49 sites
  • Auckland City Hospital
    Auckland, 1023, New Zealand
  • Middlemore Hospital
    Auckland, 2025, New Zealand
  • Christchurch Hospital
    Christchurch, 8011, New Zealand
  • Rotorua Hospital
    Rotorua, 3010, New Zealand
  • Tauranga Hospital
    Tauranga, 3112, New Zealand
  • Aberdeen Royal Infirmary
    Aberdeen, AB25 2XN, United Kingdom
  • University Hospital Monklands
    Airdrie, ML6 0JS, United Kingdom
  • William Harvey Hospital
    Ashford, TN24 0LZ, United Kingdom
  • University Hospital
    Ayr, KA6 6DX, United Kingdom
  • Blackpool Victoria Hospital
    Blackpool, FY3 8NR, United Kingdom
  • Royal Bournemouth Hospital
    Bournemouth, BH7 7DW, United Kingdom
  • Bradford Royal Infirmary
    Bradford, BD9 6RJ, United Kingdom
  • Bristol Heart Institute
    Bristol, BS2 8ED, United Kingdom
  • Cumberland Infirmary and West Cumberland Hospital
    Carlisle, CA2 7HY, United Kingdom
  • Northumbria Specialist Emergency Care Hospital
    Cramlington, NE23 6NZ, United Kingdom
  • Dorset County Hospital
    Dorchester, DT1 2JY, United Kingdom
  • Dumfries and Galloway Royal Infirmary
    Dumfries, DG2 8RX, United Kingdom
  • Ninewells Hospital
    Dundee, DD2 1GZ, United Kingdom
  • University Hospital Hairmyres
    East Kilbride, G75, United Kingdom
  • Western General Hospital
    Edinburgh, EH4 2XU, United Kingdom
  • Edinburgh Royal Infirmary
    Edinburgh, United Kingdom
  • Royal Devon and Exeter Hospital
    Exeter, EX2 5DW, United Kingdom
  • Glasgow Royal Infirmary
    Glasgow, G4 0SF, United Kingdom
  • Queen Elizabeth University Hospital
    Glasgow, G51 4TF, United Kingdom
  • Golden Jubilee National Hospital
    Glasgow, G81 4HX, United Kingdom
  • Inverclyde Royal Hospital
    Greenock, PA16 0XN, United Kingdom
  • Conquest Hospital
    Hastings, TN37 7HS, United Kingdom
  • Wycombe Hospital
    High Wycombe, HP11 2TT, United Kingdom
  • Raigmore Hospital
    Inverness, IV2 3UJ, United Kingdom
  • West Middlesex University Hospital
    Isleworth, TW7 6AF, United Kingdom
  • University Hospital Crosshouse
    Kilmarnock, KA2 0BE, United Kingdom
  • Victoria Hospital
    Kirkcaldy, KY2 5AH, United Kingdom
  • Forth Valley Royal Hospial
    Larbert, FK5 4WR, United Kingdom
  • St John's Hospital
    Livingston, EH54 6PP, United Kingdom
  • Royal Free Hospital
    London, NW3 2QG, United Kingdom
  • St Thomas' Hospital
    London, SE1 7EH, United Kingdom
  • Macclesfield District General Hospital
    Macclesfield, SK10 3BL, United Kingdom
  • Borders General Hospital
    Melrose, TD6 9BS, United Kingdom
  • James Cook Hospital
    Middlesbrough, TS4 3BW, United Kingdom
  • John Radcliffe Hospital
    Oxford, OX3 9DU, United Kingdom
  • Royal Alexandra Hospital
    Paisley, PA2 9PN, United Kingdom
  • Perth Royal Infirmary
    Perth, PH1 1NX, United Kingdom
  • Royal Berkshire Hospital
    Reading, RG1 5AN, United Kingdom
  • Northern General Hospital
    Sheffield, S5 7AU, United Kingdom
  • Southampton General Hospital
    Southampton, SO16 6YD, United Kingdom
  • Torbay Hospital
    Torquay, TQ2 7AA, United Kingdom
  • Royal Albert Edward Infirmary
    Wigan, WN1 2NN, United Kingdom
  • University Hospital
    Wishaw, ML2 0DP, United Kingdom
  • Yeovil District Hospital
    Yeovil, BA21 4AT, United Kingdom
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2018 to primary completion in Feb 2023, 57 months.

Results were first posted in Jan 2026, 2 years 11 months after primary completion.

Of 85 non-industry phase 4 interventional studies under Acute Coronary Syndrome, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 67. This study's 57 months is above that.

Counting every sponsor, half of 92 studies reached it within 42 months; a quarter within 26 and three quarters within 60.

Start moved once since we started tracking on Sep 25, 2026: Dec 2018 → Apr 2018, on Nov 3, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Aug 9, 2017
First posted
Aug 17, 2017
StartActual
Apr 26, 2018was Dec 2018
Primary completionActual
Feb 4, 2023
CompletionActual
Feb 4, 2023
Results first posted
Jan 28, 2026
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
48 sites added — first site in New Zealand
Show 48 added (43 United Kingdom, 5 New Zealand)
  • Auckland City Hospital · Auckland, New Zealand
  • Middlemore Hospital · Auckland, New Zealand
  • Christchurch Hospital · Christchurch, New Zealand
  • Rotorua Hospital · Rotorua, New Zealand
  • Tauranga Hospital · Tauranga, New Zealand
  • Aberdeen Royal Infirmary · Aberdeen, United Kingdom
  • University Hospital Monklands · Airdrie, United Kingdom
  • William Harvey Hospital · Ashford, United Kingdom
  • University Hospital · Ayr, United Kingdom
  • Blackpool Victoria Hospital · Blackpool, United Kingdom
  • Royal Bournemouth Hospital · Bournemouth, United Kingdom
  • Bradford Royal Infirmary · Bradford, United Kingdom
  • Bristol Heart Institute · Bristol, United Kingdom
  • Cumberland Infirmary and West Cumberland Hospital · Carlisle, United Kingdom
  • Northumbria Specialist Emergency Care Hospital · Cramlington, United Kingdom
  • Dorset County Hospital · Dorchester, United Kingdom
  • Dumfries and Galloway Royal Infirmary · Dumfries, United Kingdom
  • Ninewells Hospital · Dundee, United Kingdom
  • University Hospital Hairmyres · East Kilbride, United Kingdom
  • Western General Hospital · Edinburgh, United Kingdom
  • Royal Devon and Exeter Hospital · Exeter, United Kingdom
  • Glasgow Royal Infirmary · Glasgow, United Kingdom
  • Queen Elizabeth University Hospital · Glasgow, United Kingdom
  • Golden Jubilee National Hospital · Glasgow, United Kingdom
  • Inverclyde Royal Hospital · Greenock, United Kingdom
  • Conquest Hospital · Hastings, United Kingdom
  • Wycombe Hospital · High Wycombe, United Kingdom
  • Raigmore Hospital · Inverness, United Kingdom
  • West Middlesex University Hospital · Isleworth, United Kingdom
  • University Hospital Crosshouse · Kilmarnock, United Kingdom
  • …and 18 more on the registry record
Nov 3, 2026
Start date
Dec 11, 2018→Apr 26, 2018
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    48 sites added — first site in New Zealand
    Show 48 added (43 United Kingdom, 5 New Zealand)
    • Auckland City Hospital · Auckland, New Zealand
    • Middlemore Hospital · Auckland, New Zealand
    • Christchurch Hospital · Christchurch, New Zealand
    • Rotorua Hospital · Rotorua, New Zealand
    • Tauranga Hospital · Tauranga, New Zealand
    • Aberdeen Royal Infirmary · Aberdeen, United Kingdom
    • University Hospital Monklands · Airdrie, United Kingdom
    • William Harvey Hospital · Ashford, United Kingdom
    • University Hospital · Ayr, United Kingdom
    • Blackpool Victoria Hospital · Blackpool, United Kingdom
    • Royal Bournemouth Hospital · Bournemouth, United Kingdom
    • Bradford Royal Infirmary · Bradford, United Kingdom
    • Bristol Heart Institute · Bristol, United Kingdom
    • Cumberland Infirmary and West Cumberland Hospital · Carlisle, United Kingdom
    • Northumbria Specialist Emergency Care Hospital · Cramlington, United Kingdom
    • Dorset County Hospital · Dorchester, United Kingdom
    • Dumfries and Galloway Royal Infirmary · Dumfries, United Kingdom
    • Ninewells Hospital · Dundee, United Kingdom
    • University Hospital Hairmyres · East Kilbride, United Kingdom
    • Western General Hospital · Edinburgh, United Kingdom
    • Royal Devon and Exeter Hospital · Exeter, United Kingdom
    • Glasgow Royal Infirmary · Glasgow, United Kingdom
    • Queen Elizabeth University Hospital · Glasgow, United Kingdom
    • Golden Jubilee National Hospital · Glasgow, United Kingdom
    • Inverclyde Royal Hospital · Greenock, United Kingdom
    • Conquest Hospital · Hastings, United Kingdom
    • Wycombe Hospital · High Wycombe, United Kingdom
    • Raigmore Hospital · Inverness, United Kingdom
    • West Middlesex University Hospital · Isleworth, United Kingdom
    • University Hospital Crosshouse · Kilmarnock, United Kingdom
    • …and 18 more on the registry record
    Start date Dec 11, 2018→Apr 26, 2018

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID
NCT03252249
Lead sponsor
University of Edinburgh
Collaborators
British Heart Foundation
Responsible party
Sponsor
First posted
Aug 17, 2017
Start date
Apr 26, 2018
Primary completion
Feb 4, 2023
Completion
Feb 4, 2023
Results posted
Jan 28, 2026
Last update
Nov 3, 2026

Study contacts

David Newby
principal investigator · University of Edinburgh

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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