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Clopidogrel Only Before Percutaneous Coronary Intervention or Before Every Coronarography?

This study has been completed.
Sponsor:
Information provided by:
Charles University, Czech Republic
ClinicalTrials.gov Identifier:
NCT00432120
First received: February 5, 2007
Last updated: January 28, 2008
Last verified: August 2007
History of Changes
  Purpose

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:

U.S. FDA Resources

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

  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00432120

Locations
Czech Republic
Charles University
Prague, Czech Republic, 10034
Sponsors and Collaborators
Charles University, Czech Republic
Investigators
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

ClinicalTrials.gov 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
Heart Diseases
Coronary Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Clopidogrel
Ticlopidine
Platelet Aggregation Inhibitors
Hematologic Agents
 Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 16, 2013