Abrupt Versus Tapered Interruption of Chronic Clopidogrel Therapy After DES Implantation - Full Text View

Sponsor:	Deutsches Herzzentrum Muenchen
Information provided by (Responsible Party):	Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:	NCT00640679

Purpose

The hypothesis to be tested is that gradual clopidogrel therapy cessation is associated with a superior clinical outcome compared with abrupt cessation (superiority hypothesis).

Condition	Intervention	Phase
Coronary Artery Disease	Drug: Abrupt Clopidogrel Interruption Drug: Clopidogrel Tapering	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Prospective, Randomized, Double-Blind Trial of Abrupt and Tapered Interruption of Long-term Clopidogrel Therapy After Implantation of a Drug-Eluting Stent

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease

Drug Information available for: Clopidogrel Clopidogrel Bisulfate

U.S. FDA Resources

Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:

Composite of cardiac death, myocardial infarction, stent thrombosis, stroke, major bleeding or rehospitalization due to acute coronary syndrome. [ Time Frame: 3 months after randomization ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The individual components of the primary endpoint. All cause mortality. [ Time Frame: 3 months after randomization ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	3000
Study Start Date:	April 2008
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Clopidogrel Tapering	Drug: Clopidogrel Tapering Patients assigned to this group will have Clopidogrel gradually decreased according to a fixed tapering schema of Clopidogrel and Placebo over 4 weeks. Other Name: Plavix
Active Comparator: Abrupt Clopidogrel Interruption	Drug: Abrupt Clopidogrel Interruption Patients assigned to this group will receive Clopidogrel 75mg per day for an additional period of 4 weeks. Afterwards they will stop the drug abruptly. Other Name: Plavix

Detailed Description:

A possible rebound in platelet activity after clopidogrel withdrawal has been suggested in patients on chronic clopidogrel therapy. However, a systematic evaluation of the role of rapid thienopyridine withdrawal on ischemic complications in patients with treated coronary artery disease has not been addressed by specifically designed studies. The objective of this study is to evaluate the safety and efficacy of abrupt or tapered interruption of chronic clopidogrel therapy after intracoronary drug-eluting stent implantation.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with planned interruption of chronic clopidogrel therapy after DES implantation
Informed, written consent by the patient

Exclusion Criteria:

Planned surgery within the next month
Active bleeding as reason for clopidogrel discontinuation
Concomitant coumadin therapy
Pregnancy (present, suspected or planned) or positive pregnancy test (In women with childbearing potential a negative pregnancy test is mandatory)
Malignancies or other comorbid conditions with a life expectancy of less than one year or that may result in protocol noncompliance.
Patient's inability to fully comply with the study protocol.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00640679

Contacts

Contact: Julinda Mehilli, MD	+49 89 1218 ext 4073	mehilli@dhm.mhn.de
Contact: Stefanie Schulz, MD	+49 89 1218 ext 1521	schulzs@dhm.mhn.de

Locations

Germany
Deutsches Herzzentrum Muenchen	Recruiting
Munich, Germany, 80636
Contact: Julinda Mehilli, MD mehilli@dhm.mhn.de
Principal Investigator: Julinda Mehilli, MD
Medizinische Klinik, Klinikum rechts der Isar	Recruiting
Munich, Germany, 81675
Contact: Josef Dirschinger, MD +49 89 4041 ext 2947 dirschinger@med1.med.tum.de
Principal Investigator: Josef Dirschinger

Sponsors and Collaborators

Deutsches Herzzentrum Muenchen

Investigators

Study Chair:	Adnan Kastrati, MD	Deutsches Herzzentrum Muenchen
Principal Investigator:	Julinda Mehilli, MD	Deutsches Herzzentrum Muenchen

More Information

No publications provided

Responsible Party:	Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:	NCT00640679 History of Changes
Other Study ID Numbers:	GE IDE No. A01308
Study First Received:	March 17, 2008
Last Updated:	January 3, 2012
Health Authority:	Germany: Ethics Commission

Keywords provided by Deutsches Herzzentrum Muenchen:

Clopidogrel
Drug-eluting Stent

Additional relevant MeSH terms:

Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
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 February 09, 2012