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Twelve vs 24 Months of Dual Antiplatelet Therapy in Patients With Coronary Revascularization for In-stent Restenosis

NCT02402491 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2015-03-30

No results posted yet for this study

Summary

Patients undergoing the percutaneous coronary intervention (PCI) for in-stent restenosis (ISR) are enrolled. All patients will be randomized to receive either 12 months or 24 months of dual antiplatelet therapy with a P2Y12 receptor antagonist in addition to aspirin, all patients continue receiving aspirin indefinitely. The primary efficacy end points of this study are the incidence of a composite end point including all cause deaths, myocardial infarction, the incidence of Academic Research Consortium defined definite or probable stent thrombosis and stroke (MACCE) at 24 months. The primary safety end point is the incidence of GUSTO moderate or severe bleeding.

Conditions

  • Percutaneous Coronary Intervention

Interventions

DRUG

12 months of P2Y12 receptor antagonist

All subjects will be received 12 months of dual antiplatelet therapy with a P2Y12 receptor antagonist (clopidogrel/prasugrel/ticagrelor) in addition to aspirin.

DRUG

24 months of P2Y12 receptor antagonist

All subjects will be received 24 months of dual antiplatelet therapy with a P2Y12 receptor antagonist (clopidogrel/prasugrel/ticagrelor) in addition to aspirin.

DRUG

Aspirin

The maintenance dose of aspirin is 100 mg daily, to be taken indefinitely.

Sponsors & Collaborators

  • Beijing Anzhen Hospital

    lead OTHER

Principal Investigators

  • Yujie Zhou, MD, PhD · Beijing Anzhen Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02402491 on ClinicalTrials.gov