Clopidogrel Only Before Percutaneous Coronary Intervention or Before Every Coronarography?

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2007-07-31

Brief Summary

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Clopidogrel pre-treatment before planned percutaneous coronary intervention was proved to reduce periprocedural complications. However, the vast majority of patients in the current interventional cardiology practice do not undergo planned PCI, but rather "ad-hoc" PCI performed immediately after coronary angiography . Whether clopidogrel should be administered as pre-treatment to all patients undergoing elective CAG with the aim to ensure therapeutic levels at the time of possible ad-hoc PCI is not known.

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Detailed Description

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Conditions

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Ischemic Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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A

"nonselective" - clopidogrel 600 mg \>6 hours before coronary angiography;

Group Type ACTIVE_COMPARATOR

clopidogrel

Intervention Type DRUG

To compare two different clopidogrel regimens on the outcomes of patients undergoing elective coronary angiography ± ad-hoc percutaneous coronary intervention

B

"selective" - clopidogrel 600 mg in the cath-lab after coronary angiography, only in case of percutaneous coronary intervention

Group Type ACTIVE_COMPARATOR

clopidogrel

Intervention Type DRUG

To compare two different clopidogrel regimens on the outcomes of patients undergoing elective coronary angiography ± ad-hoc percutaneous coronary intervention

Interventions

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clopidogrel

To compare two different clopidogrel regimens on the outcomes of patients undergoing elective coronary angiography ± ad-hoc percutaneous coronary intervention

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age ≥ 18 years
2. Elective CAG for suspected or proven coronary artery disease (stable forms or fully stabilized acute coronary syndrome)
3. Signed written informed consent

Exclusion Criteria

1. Thienopyridine treatment in previous two weeks
2. Contraindication for clopidogrel
3. CAG scheduled less than 6 hours after potential randomization
4. Clinically significant bleeding (i.e. with hemoglobin fall by \> 50 g/l and/or requiring transfusions or surgery) in previous 3 months.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No