Clopidogrel Only Before Percutaneous Coronary Intervention or Before Every Coronarography?

This study has been completed.
Information provided by:
Charles University, Czech Republic Identifier:
First received: February 5, 2007
Last updated: January 28, 2008
Last verified: August 2007
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.

Condition Intervention Phase
Ischemic Heart Disease
Drug: clopidogrel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Clopidogrel Loading Dose for ad-Hoc Percutaneous Coronary Intervention Immediately Following Elective Coronary Angiography: Randomized Multicenter Trial Comparing Pre-Treatment > 6 Hours Before Every Angiography vs. Cath-Lab Administration After Angiography (Just Before Intervention): the PRAGUE-8 Trial.

Resource links provided by NLM:

Further study details as provided by Charles University, Czech Republic:

Primary Outcome Measures:
  • Primary end point was the first clinical occurrence of any of the following: death / periprocedural myocardial infarction / stroke or transient ischemic attack / re-intervention [ Time Frame: within 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary end-points were periprocedural troponin elevation (> 3x ULN), TIMI-flow after PCI, bleeding complications and each individual component of the combined primary endpoint [ Time Frame: within 7 day ] [ Designated as safety issue: Yes ]

Study Start Date: March 2006
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
"nonselective" - clopidogrel 600 mg >6 hours before coronary angiography;
Drug: clopidogrel
To compare two different clopidogrel regimens on the outcomes of patients undergoing elective coronary angiography ± ad-hoc percutaneous coronary intervention
Active Comparator: B
"selective" - clopidogrel 600 mg in the cath-lab after coronary angiography, only in case of percutaneous coronary intervention
Drug: clopidogrel
To compare two different clopidogrel regimens on the outcomes of patients undergoing elective coronary angiography ± ad-hoc percutaneous coronary intervention


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both

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.
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Please refer to this study by its identifier: NCT00432120

Czech Republic
Charles University
Prague, Czech Republic, 10034
Sponsors and Collaborators
Charles University, Czech Republic
Principal Investigator: Petr Widimsky, MD Charles University, Prague, Czech Republic
Principal Investigator: Zuzana Motovska, MD Charles University, Prague, Czech Republic
  More Information

No publications provided Identifier: NCT00432120     History of Changes
Other Study ID Numbers: PRAGUE 8
Study First Received: February 5, 2007
Last Updated: January 28, 2008
Health Authority: Czech Republic: State Institute for Drug Control

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Vascular Diseases
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Purinergic Agents
Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists
Therapeutic Uses processed this record on November 25, 2015