ClinicalTrials.gg
CompletedNCT03357874TROUPERUpdated Jun 27, 2025

TicagRelor Or Clopidogrel in Severe and Terminal Chronic Kidney Disease Patients Undergoing PERcutaneous Coronary Intervention for an Acute Coronary Syndrome.

A Phase 3 interventional study of Clopidogrel and Ticagrelor in Acute Coronary Syndrome, sponsored by Assistance Publique Hopitaux De Marseille. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-27.

Sponsored by Assistance Publique Hopitaux De Marseille · Phase 3, Interventional, and Treatment

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Phase
Phase 3
Study type
Interventional
Enrollment
259
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 34 studies testing clopidogrel in Acute Coronary Syndrome — 3 open to participants now, 3 under way, none of them phase 3. Clopidogrel · Acute Coronary Syndrome.

Enrollment
14th of 33
259 · median 200
Started
2018
the only one that year
Phase 3
8 of 34
none open now
Registered
28th of 34
by date
Lead sponsor
2 of 34
Assistance Publique Hopitaux De Marseille

Among the 34 studies testing clopidogrel in Acute Coronary Syndrome, this one is the 14th largest by enrollment of the 33 interventional ones that give a count, is the only one that started in 2018, is one of 8 in phase 3, and was the 28th 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

3 of the 34 studies testing clopidogrel in Acute Coronary Syndrome are open now, in 3 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 3 open studies →

About clopidogrel

Clopidogrel: first FDA approval 1997 (PLAVIX), first EMA approval 1998. What it is approved for, and how studies give it, is on its page →

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 →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 34 studies testing clopidogrel in Acute Coronary Syndrome, or all of them as a file.
02

Study summary

Ticagrelor is a potent and fast-acting P2Y12-ADP receptor antagonist recommended as first-line agent in ACS (2). This drug was associated with a 20% relative reduction in the rate of MACE in ACS patients undergoing PCI compared to clopidogrel. This benefit came without any increase in major bleedings compared to clopidogrel (6).

In the PLATO trial, a limited number of kidney failure patients were included (21%) and patients with terminal CKD were excluded. A sub-group analysis focused on CKD patients was performed. Only 214 patients with CKD below stage 4 (creatinine clearance \<30 ml/min) were included (7). No patient with terminal CKD or undergoing chronic hemodialysis was included.

Of importance, kidney function impairment is frequent and affects up-to 40 % of ACS patients. In addition, CKD is a powerful independent predictor of ischemic complications during ACS (8-9).Indeed, CKD patients have a very high risk of MACE following ACS with an odd ratio between 2 and 3 compared to patients with normal kidney function and event rates above 40% at one year follow-up (8-13). Of importance these patients more often have high on-clopidogrel platelet reactivity which was strongly associated with a worse clinical outcome (3,14-16). In CKD patients HTPR was associated with death after PCI (15). Accordingly ticagrelor which overcomes these limitations of clopidogrel could be associated with a major clinical benefit in severe or terminal CKD patients.

Most of ticagrelor and is active metabolites are excreted through the feces. Preclinical data suggested that renal impairment had little effect on systemic exposure to the drug(EMEA/H/C/1241 (28)). Recent pharmacodynamic and kinetic studies confirmed these preclinical data on the safety of ticagrelor in severe and end-stage CKD (17-19).

Therefore based on the rational above and to the lack of relevant clinical data, the optimal P2Y12-ADP receptor antagonist for patients with stage 4 and 5 and patients undergoing chronic dialysis remains undetermined in ACS treated with PCI.

We aimed to compare the clinical efficacy ticagrelor and clopidogrel in patients with stage 4 and 5 or on chronic hemodialysis undergoing PCI for ACS.

03

Conditions studied

  • Acute Coronary Syndrome
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

- Must not be of (1 year , or surgically sterile).

non-ST-segment elevation ACS defined by the presence of at least 2 of the following criteria: (1) symptoms of myocardial ischemia, (2) electrocardiographic ST-segment abnormalities (depression or transient elevation of at least 0.1 mV) or T-wave inversion in at least in 2 contiguous leads, or (3) an elevated cardiac troponin value (above the ) (2) or ST segment elevation ACS scheduled for primary PCI defined (22)as a history of chest discomfort or ischemic symptoms of >20 minutes duration at rest ≤14 days prior to entry into the study with one of the following present on at least one prior to randomization:

  1. ST-segment elevation ≥1 mm in two or more contiguous ECG leads.
  2. New or presumably new left bundle branch block (LBBB).
  3. ST-segment depression ≥1 mm in two anterior precordial leads (V1 through V4) with clinical history and evidence suggestive of true posterior infarction

    • Subject intended for an invasive strategy if NSTE-ACS or primary PCI if STE-ACS according to guidelines (annexe 1)
    • Subject CKD stage 4 and 5 (estimated (eGFR) \<30 ml/min/1.73 m2 by (MDRD formula) or undergoing chronic dialysis
    • Must be enrolled at a cardiac catheterization laboratory hospital or at a hospital/ambulance service affiliated with a cardiac catheterization laboratory hospital.
    • Subject affiliated to or beneficiary of a social security system.
    • Subject having signed written .

Exclusion criteria

Exclusion Criteria:

  • Minors, pregnant or breast-feeding women;
  • Subject under chronic anticoagulant
  • Subject with thrombolytic therapy during the preceding 24 hours;
  • Subject with bleeding ;
  • Subject participating in another research protocol;
  • Subject not agreeing to participate.
  • Subject with to clopidogrel or ticagrelor
  • Severe hepatic failure
  • Ischemic Stroke within one month or a history of hemorrhagic stroke
  • Bradycardia
  • count\<100 000
  • Major surgery or trauma within 10 days
  • \<1 year
  • Known significant bleeding risk according to the physician judgment
Terms in these criteria, in plain language(10)

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.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

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.

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.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
259 participants (actual)

Study arms

  • Experimental
    Clopidogrel group

    Drug: Clopidogrel

  • Experimental
    Ticagrelor group

    Drug: Ticagrelor

Interventions

  • 600 mg loading dose of clopidogrel as pretreatment followed by 75 mg daily for 12 months (52 weeks).

  • patients will receive a 180 mg loading dose as pretreatment of PCI followed by 90 mg bi-daily for 12 months (52 weeks).

06

What researchers measure

Primary outcomes

  1. the rate of major adverse cardiovascular events

    Time frame: 12 MONTHS

Secondary outcomes

  1. the rate of bleedings

    using the Bleeding Academic Research Consortium classification ≥3 defined at discharge

    Time frame: 1 MONTH AND 12MONTHS

  2. the rate of myocardial infarction at discharge

    Time frame: 1 MONTH AND 12MONTHS

  3. the rate of cardiovascular death at discharge

    Time frame: 1MONTH AND 12 MONTHS

  4. the rate of urgent revascularization at discharge

    Time frame: 1MONTH AND 12 MONTHS

  5. the rate of all-cause death at discharge

    Time frame: 1MONTH AND 12 MONTHS

  6. the rate of hospital re-admission

    Time frame: 1MONTH AND 12 MONTHS

  7. the rate of probable and definite stent thrombosis (ARC definition) at discharge

    Time frame: 1MONTH AND 12 MONTHS

07

Study locations

1 site
  • APHM
    Marseille, 13354, France
08

References and documents

Publications

  • Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4. PubMed 35224730 ↗
  • Laine M, Lemesle G, Burtey S, Cayla G, Range G, Quaino G, Canault M, Pankert M, Paganelli F, Puymirat E, Bonello L. TicagRelor Or Clopidogrel in severe or terminal chronic kidney patients Undergoing PERcutaneous coronary intervention for acute coronary syndrome: The TROUPER trial. Am Heart J. 2020 Jul;225:19-26. doi: 10.1016/j.ahj.2020.04.013. Epub 2020 Apr 30. PubMed 32473355 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar 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 Oct 2018 to primary completion in Jan 2023, 50 months.

Of 39 phase 3 interventional studies under Acute Coronary Syndrome, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 52. This study's 50 months is above that.

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

Registered
Nov 14, 2017
First posted
Nov 30, 2017
StartActual
Oct 28, 2018
Primary completionActual
Jan 1, 2023
CompletionActual
Jul 18, 2023
Last update
Jun 27, 2025
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.
No changes since tracking began. The registry record was last updated on Jun 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03357874
Responsible party
Sponsor
First posted
Nov 30, 2017
Start date
Oct 28, 2018
Primary completion
Jan 1, 2023
Completion
Jul 18, 2023
Last update
Jun 27, 2025

Study contacts

jean -olivier ARNAUD
study director · AP HM

Oversight

Data monitoring committee
No
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 Jun 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Clopidogrel · Ticagrelor

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