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RecruitingNCT04240834LD-ASPIRINUpdated Jun 18, 2024

Ticagrelor With Low-dose Versus Regular Aspirin in Patients With Acute Coronary Syndrome (ACS) at High-Risk for Ischemia After Percutaneous Coronary Intervention

A Phase 4 interventional study of Aspirin and Ticagrelor in Acute Coronary Syndrome and Interventional Cardiology, sponsored by Fu Wai Hospital, Beijing, China. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-18.

Sponsored by Fu Wai Hospital, Beijing, China · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Feb 2021; still recruiting 5 years 8 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
1,220
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The present study is aimed to compare the safety and efficacy of Ticagrelor with low-dose Aspirin versus standard dual anti-platelet therapy (DAPT) in patients with acute coronary syndrome (ACS) at high risk for ischemic events after percutaneous coronary intervention (PCI) and stent implantation.

Read the detailed description

This is a prospective, randomized, open-label, blinded-endpoint evaluation, single-center Study. There will be 1220 ACS patients at high risk for ischemic events after successful PCI with implantation of at least one drug eluting stent who will be enrolled in Fuwai Hospital, China. Then those included subjects will be randomized to either Ticagrelor plus low-dose Aspirin (50mg daily, LD group) or Ticagrelor plus regular dose Aspirin (75mg daily, control group) for 12 months. The primary endpoint of the current study is to determine the impact of low-dose Aspirin plus Ticagrelor versus standard DAPT for 12 months on major adverse cardiac and cerebral events (MACCEs), and the secondary endpoint is to determine whether the protocol of low dose Aspirin plus Ticagrelor reduces bleeding events, sufficiently inhibits platelet function, and increases the medication adherence among the included patients. In summary, the present study is to provide new evidence and strategy about the anti-platelet protocol for ACS patients at high risk for ischemia.

02

Conditions studied

  • Acute Coronary Syndrome
  • Interventional Cardiology

Keywords

  • ACS
  • PCI
  • DAPI
  • Aspirin
  • Ticagrelor
03

In context

Acute Coronary Syndrome

1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.

This study's planned enrollment of 1,220 is above the median of 200 across 869 interventional studies indexed under Acute Coronary Syndrome.

Browse Acute Coronary Syndrome studies →

Lead sponsor

Fu Wai Hospital, Beijing, China is the lead sponsor of 13 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Inclusion criteria

  • ACS patients at high risk for ischemic events after successful PCI with implantation of at least one drug eluting stent
  • Able and willing to provide informed consent and participate in 12 months follow-up period
  • Able to receive DAPT treatment
  • Enrollment into the study will require meeting at least one angiographic or clinical inclusion and none of the exclusion criteria.

Clinical inclusion criteria:

  1. Family history of premature coronary heart disease (Coronary heart disease in first-degree male relative \<55 years old or in first-degree female relative \<65 years old)
  2. Repeated myocardial infarction
  3. Positive serum cardiac troponin I/T
  4. Combined with at least one organ/system with atherosclerotic disease (e.g. intracranial or peripheral arteries)
  5. Type 2 diabetes mellitus under medication
  6. Chronic kidney disease (eGFR\<60 mL/min/1.73 m2 or CrCl\<60ml/min)

Angiographic Inclusion Criteria:

  1. LM lesion requiring stents
  2. Proximal LAD lesion(s) requiring stents
  3. Bypass grafts lesion(s) requiring stents
  4. Overall stent length ≥60 mm
  5. History of in-stent thrombosis
  6. Bifurcation lesions requiring at least 2 stents
  7. Over two vessels lesions requiring stents
  8. Calcified target lesion(s) requiring atherectomy
  9. The intraoperative occurrence of no-reflow or slow-flow
  10. Compressed branch vessels with a diameter of at least 2.0 mm failing to reach flow restoration (at least TIMI 3)

Exclusion criteria

Exclusion Criteria:

  • Need for chronic oral anticoagulation
  • With cardiomyopathy（HCM/DCM/RCM）
  • With severe ventricular arrhythmia requiring ICD implantation
  • With chronic respiratory disease (COPD, asthma, chronic bronchitis, pulmonary heart disease)
  • With severe infectious disease（active hepatitis B, active hepatitis C, AIDS）
  • With hematological disorders（thrombocytopenia, severe anemia, leukaemia）
  • With severe liver disease or kidney failure
  • With malignant tumor
  • With cognitive impairment
  • Unable or unwilling to provide informed consent or undergo follow-up
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
1,220 participants (estimated)

Study arms

  • Experimental
    LD group

    Low-dose Aspirin(50mg qd) + Ticagrelor( 90mg bid) for 12 months

    Drug: Aspirin · Drug: Ticagrelor

  • Active comparator
    Control group

    Regular Aspirin(75mg qd) + Ticagrelor(90mg bid) for 12 months

    Drug: Aspirin · Drug: Ticagrelor

Interventions

  • DrugAspirin

    Comparison of 12 months of ticagrelor and low-dose aspirin versus 12 months of standard dual anti-platelet therapy (DAPT)

    Also known as: Acetylsalicylic Acid

  • DrugTicagrelor

    Comparison of 12 months of ticagrelor and low-dose aspirin versus 12 months of standard dual anti-platelet therapy (DAPT)

    Also known as: Brilinta/Brilique

06

What researchers measure

Primary outcomes

  1. Major adverse cardiac and cerebral events (MACCEs)

    Number of participants with a composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke or urgent target vessel revascularization

    Time frame: 12 months after randomization

Secondary outcomes

  1. Bleeding episode (Key secondary endpoint)

    Number of participants with major bleeding(Bleeding Academic Research Consortium (BARC) types ≥3) and/or minor bleeding(Bleeding Academic Research Consortium (BARC) types 0-2)

    Time frame: 12 months after randomization

  2. Platelet function

    Platelet inhibition, blood level and urine level of thromboxaneB2(TXB2)

    Time frame: 12 months after randomization

  3. Medication adherence

    Time frame: 12 months after randomization

  4. Bleeding-related withdrawal

    Time frame: 12 months after randomization

07

Study locations

1 of 1 sites recruiting
  • Fuwai Hospital
    Beijing, Beijing, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04240834
Lead sponsor
Fu Wai Hospital, Beijing, China
Responsible party
Qian Haiyan (MD, PhD, Fu Wai Hospital, Beijing, China) — Principal investigator
First posted
Jan 27, 2020
Start date
Feb 1, 2021
Primary completion
Dec 2025 (estimated)
Completion
Dec 2026 (estimated)
Last update
Jun 18, 2024

Study contacts

Haiyan Qian, MD, PhD
Contact
ahqhy712@163.com
+8613811386143
Zhiyao Wei
Contact
weizhiyaoyx@163.com
+8615521192379
Haiyan Qian, MD, PhD
principal investigator · Fuwai Hospital, Beijing, China

Oversight

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

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