Clopidogrel Reloading in Patients With NSTEACS Undergoing Percutaneous Coronary Intervention on Chronic Clopidogrel Therapy

Campus Bio-Medico University of Rome

Status and phase: Unknown; Phase 4

Conditions: Acute Coronary Syndrome; Myocardial Infarction

Treatments: Drug: Placebo; Drug: Clopidogrel

Study type: Interventional

Funder types: Other

Identifiers

NCT01572129

2011-005449-11

Details and patient eligibility

About

Patients who developed an acute coronary syndrome despite dual antiplatelet therapy with aspirin and clopidogrel may benefit from a further dose of clopidogrel before a percutaneous coronary intervention.

The aim of this study is to evaluate safety and effectiveness of clopidogrel reloading in patients on chronic clopidogrel therapy with acute coronary syndrome undergoing percutaneous coronary intervention.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• chronic (> 10 days) therapy with clopidogrel (75 mg/day)
• non-ST-segment elevation acute coronary syndrome (ACS) requiring early diagnostic angiography

Exclusion criteria

• primary percutaneous coronary intervention (PCI) for acute ST-segment elevation acute myocardial infarction
• platelet count < 70 × 10^9/L
• high bleeding risk
• coronary bypass grafting in the previous 3 months

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 2 patient groups, including a placebo group

Reload

Experimental group

Description:

600 mg of clopidogrel loading dose 6-8 h before coronary angiogram, in addition to the chronic daily dose of 75 mg

Treatment:

Drug: Clopidogrel

Placebo

Placebo Comparator group

Description:

Placebo arm in addition to the chronic daily dose of 75 mg

Treatment:

Drug: Placebo