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

NCT00140465 | Completed Phase 4 DMC

• 1 other identifier: GE IDE No. A00803
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Coronary Disease

Outcome Measures

Primary Outcomes (1)

• Maximal ADP(5µmol/l)-induced platelet aggregation 30 days after the intervention

  30 days after the intervention

Secondary Outcomes (2)

• Maximal ADP(20µmol/l)-induced platelet aggregation 30 days after the intervention

  30 days after the intervention

• P2Y12 inhibition measured by point-of-care test

  P2Y12 inhibition measured by point-of-care test

Study Arms (2)

1

ACTIVE COMPARATOR

75 mg Clopidogrel Maintenance Doses

Drug: Clopidogrel

2

ACTIVE COMPARATOR

150 mg Clopidogrel Maintenance Doses

Drug: Clopidogrel

Interventions

Clopidogrel DRUG

after PCI

Also known as: Iscover, Plavix

1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Deutsches Herzzentrum Muenchen: lead
• Technical University of Munich: collaborator

Study Sites (1)

Deutsches Herzzentrum Muenchen

Munich, 80636, Germany

Location

Related Publications (7)

• Steinhubl SR, Berger PB, Mann JT 3rd, Fry ET, DeLago A, Wilmer C, Topol EJ; CREDO Investigators. Clopidogrel for the Reduction of Events During Observation. Early and sustained dual oral antiplatelet therapy following percutaneous coronary intervention: a randomized controlled trial. JAMA. 2002 Nov 20;288(19):2411-20. doi: 10.1001/jama.288.19.2411.

  PMID: 12435254 BACKGROUND

• Pache J, Kastrati A, Mehilli J, Gawaz M, Neumann FJ, Seyfarth M, Hall D, Braun S, Dirschinger J, Schomig A. Clopidogrel therapy in patients undergoing coronary stenting: value of a high-loading-dose regimen. Catheter Cardiovasc Interv. 2002 Apr;55(4):436-41. doi: 10.1002/ccd.10092.

  PMID: 11948888 BACKGROUND

• Kastrati A, Mehilli J, Schuhlen H, Dirschinger J, Dotzer F, ten Berg JM, Neumann FJ, Bollwein H, Volmer C, Gawaz M, Berger PB, Schomig A; Intracoronary Stenting and Antithrombotic Regimen-Rapid Early Action for Coronary Treatment Study Investigators. A clinical trial of abciximab in elective percutaneous coronary intervention after pretreatment with clopidogrel. N Engl J Med. 2004 Jan 15;350(3):232-8. doi: 10.1056/NEJMoa031859.

  PMID: 14724302 BACKGROUND

• Muller I, Seyfarth M, Rudiger S, Wolf B, Pogatsa-Murray G, Schomig A, Gawaz M. Effect of a high loading dose of clopidogrel on platelet function in patients undergoing coronary stent placement. Heart. 2001 Jan;85(1):92-3. doi: 10.1136/heart.85.1.92. No abstract available.

  PMID: 11119474 BACKGROUND

• 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. doi: 10.1161/01.cir.0000037106.76139.53. No abstract available.

  PMID: 12356647 BACKGROUND

• Gorchakova O, von Beckerath N, Gawaz M, Mocz A, Joost A, Schomig A, Kastrati A. Antiplatelet effects of a 600 mg loading dose of clopidogrel are not attenuated in patients receiving atorvastatin or simvastatin for at least 4 weeks prior to coronary artery stenting. Eur Heart J. 2004 Nov;25(21):1898-902. doi: 10.1016/j.ehj.2003.10.039.

  PMID: 15522468 BACKGROUND

• Kastrati A, von Beckerath N, Joost A, Pogatsa-Murray G, Gorchakova O, Schomig A. Loading with 600 mg clopidogrel in patients with coronary artery disease with and without chronic clopidogrel therapy. Circulation. 2004 Oct 5;110(14):1916-9. doi: 10.1161/01.CIR.0000137972.74120.12. Epub 2004 Jul 19.

  PMID: 15262828 BACKGROUND

MeSH Terms

Conditions

Coronary Disease

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Albert Schomig, MD

  Deutsches Herzzentrum Muenchen

  STUDY CHAIR

• Adnan Kastrati, MD

  Deutsches Herzzentrum Muenchen

  STUDY DIRECTOR

• Nicolas von Beckerath, MD

  Deutsches Herzzentrum Muenchen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 31, 2005
• First Posted: September 1, 2005
• Study Start: October 1, 2004
• Study Completion: July 1, 2005
• Last Updated: November 14, 2007

Record last verified: 2007-11

Locations

DE (1)