75 or 150 mg Clopidogrel Maintenance Doses Following PCI (ISAR-CHOICE-2)

This study has been completed.
Sponsor:
Collaborator:
Technische Universität München
Information provided by:
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT00140465
First received: August 31, 2005
Last updated: November 13, 2007
Last verified: November 2007
  Purpose

The purpose of the study is to test whether an increase of the maintenance dose of clopidogrel from 75 to 150 mg per day results in an additional suppression of ADP-induced platelet aggregation


Condition Intervention Phase
Coronary Disease
Drug: Clopidogrel
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized Comparison Between Two Different Clopidogrel Maintenance Doses After Percutaneous Coronary Intervention (ISAR-CHOICE-2)

Resource links provided by NLM:


Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • Maximal ADP(5µmol/l)-induced platelet aggregation 30 days after the intervention [ Time Frame: 30 days after the intervention ]

Secondary Outcome Measures:
  • Maximal ADP(20µmol/l)-induced platelet aggregation 30 days after the intervention [ Time Frame: 30 days after the intervention ]
  • P2Y12 inhibition measured by point-of-care test [ Time Frame: P2Y12 inhibition measured by point-of-care test ]

Enrollment: 60
Study Start Date: October 2004
Study Completion Date: July 2005
Arms Assigned Interventions
Active Comparator: 1
75 mg Clopidogrel Maintenance Doses
Drug: Clopidogrel
after PCI
Other Names:
  • Iscover
  • Plavix
Active Comparator: 2
150 mg Clopidogrel Maintenance Doses
Drug: Clopidogrel
after PCI
Other Names:
  • Iscover
  • Plavix

Detailed Description:

In patients treated with coronary stents clopidogrel therapy is usually initiated with a 300 to 600 mg loading dose. In the CREDO trial it was shown that a 300 mg loading dose results in a reduction of ischemic events after percutaneous coronary intervention (PCI) if given 6 hours prior to the procedure. An antiplatelet effect similar to that achieved by chronic therapy with 75 mg/day is reached within 2 hours when the high 600 mg loading is administered. The 600 mg loading dose has been shown to be safe and effective in preventing thrombotic events following coronary stent implantation. Recently, it was shown that in patients with stable angina and administration of the 600 mg loading dose at least two hours prior to PCI concomitant therapy with a GP IIb/IIIa antagonist does not result in a further reduction of the incidence of thrombotic events. In contrast to a number of investigations with different loading doses, no trials have been performed comparing different clopidogrel maintenance doses. Recently, it was shown that administration of a 600 mg loading dose in patients already on chronic clopidogrel therapy (75 mg/day) results in an additional significant increase in inhibition of adenosine diphosphate (ADP-) induced platelet aggregation. Therefore, it is possible that an increase of the clopidogrel maintenance dose in patients with chronic clopidogrel therapy also results in a more pronounced inhibition of platelet aggregation.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with chronic aspirin therapy who are treated with percutaneous coronary intervention at least 2 hours after administration of a 600 mg loading dose of clopidogrel

Exclusion Criteria:

  • Major alterations of blood count (particularly platelet count < 100x10^9/l, haemoglobin < 10 mg/dl
  • Recent bleeding diathesis
  • Presence of a hematologic or malignant disorder
  • Oral anticoagulation with coumarin derivates
  • Use of glycoprotein (GP) IIb/IIIa antagonists during the intervention or during the preceding 14 days
  • Therapy with clopidogrel within the last 28 days
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00140465

Locations
Germany
Deutsches Herzzentrum Muenchen
Munich, Germany, 80636
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Technische Universität München
Investigators
Study Chair: Albert Schomig, MD Deutsches Herzzentrum Muenchen
Study Director: Adnan Kastrati, MD Deutsches Herzzentrum Muenchen
Principal Investigator: Nicolas von Beckerath, MD Deutsches Herzzentrum Muenchen
  More Information

Publications:
Braunwald E, Antman EM, Beasley JW, Califf RM, Cheitlin MD, Hochman JS, Jones RH, Kereiakes D, Kupersmith J, Levin TN, Pepine CJ, Schaeffer JW, Smith EE 3rd, Steward DE, Theroux P, Gibbons RJ, Alpert JS, Faxon DP, Fuster V, Gregoratos G, Hiratzka LF, Jacobs AK, Smith SC Jr; American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on the Management of Patients With Unstable Angina). ACC/AHA guideline update for the management of patients with unstable angina and non-ST-segment elevation myocardial infarction--2002: summary article: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on the Management of Patients With Unstable Angina). Circulation. 2002 Oct 1;106(14):1893-900. No abstract available.

ClinicalTrials.gov Identifier: NCT00140465     History of Changes
Other Study ID Numbers: GE IDE No. A00803
Study First Received: August 31, 2005
Last Updated: November 13, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive 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 July 22, 2014