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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorFu Wai Hospital, Beijing, China

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Repeated myocardial infarction

Positive serum cardiac troponin I/T

Combined with at least one organ/system with atherosclerotic disease (e.g. intracranial or peripheral arteries)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Aspirin

    Drug

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

  • Ticagrelor

    Drug

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

Treatment groups

1,220 Participants
are divided into 2 treatment groups
Group A: LD groupExperimental treatment 2 interventions
Group B: Control groupActive comparator 2 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

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