Clopidogrel Optimal Loading Dose Usage to Reduce Recurrent EveNTs/Optimal Antiplatelet Strategy for InterventionS

Sanofi25,086 enrolled

Overview

The purpose of this study is to evaluate whether a higher dosage of clopidogrel with aspirin (two doses) will decrease the risk of ischemic complications (cardiac death (CV death), myocardial infarction (MI), stroke) after a percutaneous coronary intervention (PCI).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

25,086

Conditions

Acute Coronary Disease Angina Unstable

Interventions

ClopidogrelDRUG

oral administration

acetylsalicyclic acid (ASA)DRUG

oral administration

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosed with acute coronary disease with clinical symptoms and at least electrocardiogram changes or cardiac enzymes elevated Exclusion Criteria: * Use of anticoagulants within 10 days with an international normalized ratio (INR) \> 1.5 or planned use during the hospitalisation period * Administration of clopidogrel \> 75 mg prior to randomization * Contraindication to clopidogrel or aspirin * Active bleeding or significant risk of bleeding

Locations (38)

Outcomes

Primary Outcomes

First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison

The primary endpoint is the first occurrence of any of the following events: * Cardiovascular death (any death with a clear cardiovascular or unknown cause), * Myocardial Infarction (diagnosis of new Myocardial Infarction (MI) - nonfatal or fatal) * Stroke (presence of a new focal neurologic deficit thought to be vascular in origin, with signs or symptoms lasting more than 24 hours - nonfatal or fatal) reported between the randomization and Day 30 (inclusive), and validated by the blinded Event Adjudication Committee (EAC).

Time frame: 30 days

First Occurrence of CV Death / MI / Stroke - ASA Dose Comparison

Time frame: 30 days

First Occurrence of CV Death / MI / Stroke - Interaction Clopidogrel Treatment Regimen and ASA Dose Level

Time frame: 30 days

First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison in PCI Subgroup

Time frame: 30 days

Secondary Outcomes

Occurrence of Major Bleeding - Clopidogrel Dose Regimen Comparison

Major bleeding is defined as any severe bleeding (associated with any of the following: death, leading to a drop in hemoglobin ≥ 5 g/dl, significant hypotension with the need for inotropic agents, symptomatic intracranial hemorrhage, requirement for surgery or for a transfusion ≥ 4 units of red blood cells or equivalent whole blood) and other major bleeding (significantly disabling bleeding, or intraocular bleeding leading to significant loss of vision or bleeding requiring transfusion of 2-3 units of red blood cells or equivalent whole blood) after validation by the independent EAC.

Time frame: 30 days

Occurrence of Major Bleeding - ASA Dose Level Comparison

Data from ClinicalTrials.gov

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