Pilot Study of Continuing Aspirin Versus Switching to Clopidogrel After Stroke or Transient Ischemic Attack

This study has been withdrawn prior to recruitment.

First Received: August 10, 2006 Last Updated: March 30, 2007 History of Changes

Sponsored by:	University of California, San Diego
Information provided by:	University of California, San Diego
ClinicalTrials.gov Identifier:	NCT00363753

Purpose

Pilot study of continuing aspirin versus switching to clopidogrel after stroke or transient ischemic attack.

Condition	Intervention	Phase
Transient Ischemic Attack Stroke Aspirin Clopidogrel	Drug: aspirin versus clopidogrel	Phase I

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Pilot Study of Continuing Aspirin Versus Switching to Clopidogrel After Stroke or Transient Ischemic Attack

Resource links provided by NLM:

MedlinePlus related topics: Transient Ischemic Attack

Drug Information available for: Acetylsalicylic acid Clopidogrel Clopidogrel Bisulfate

U.S. FDA Resources

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:

mRS at three months.

Secondary Outcome Measures:

Incidence of stroke at three months, bleeding events.

Estimated Enrollment:	20
Study Start Date:	August 2006
Estimated Study Completion Date:	March 2007

Detailed Description:

Pilot study of continuing aspirin versus switching to clopidogrel after stroke or transient ischemic attack.

Eligibility

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

Criteria

Inclusion Criteria:

Age 18 and older.
Stroke or transient ischemic attack (TIA) while taking aspirin within one week of consent.
Women of child-bearing potential will be included only if there is a negative pregnancy test and they agree to birth control during the treatment period.

Exclusion Criteria:

Any medical indication for a specific antiplatelet agent (aspirin, clopidogrel, ticlopidine, aggrenox), or an indication for a combination of antiplatelet agents.
Any medical indication for anticoagulation, except subcutaneous heparin for deep vein thrombosis prophylaxis.
Allergy to aspirin or clopidogrel.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00363753

Locations

United States, California
UCSD Hillcrest
San Diego, California, United States, 92103
UCSD
San Diego, California, United States, 92103

Sponsors and Collaborators

University of California, San Diego

Investigators

Principal Investigator:

Matt B Jensen, MD

UCSD Stroke Center

More Information

No publications provided

Study ID Numbers:	UCSD IRB #060452
Study First Received:	August 10, 2006
Last Updated:	March 30, 2007
ClinicalTrials.gov Identifier:	NCT00363753 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Diego:

Transient ischemic attack
Stroke
Aspirin
Clopidogrel

Study placed in the following topic categories:

Anti-Inflammatory Agents
Ischemic Attack, Transient
Cerebral Infarction
Cyclooxygenase Inhibitors
Stroke
Vascular Diseases
Central Nervous System Diseases
Fibrinolytic Agents
Cardiovascular Agents
Ischemia
Brain Diseases
Cerebrovascular Disorders

Fibrin Modulating Agents
Aspirin
Analgesics, Non-Narcotic
Clopidogrel
Brain Ischemia
Platelet Aggregation Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Brain Infarction
Antirheumatic Agents
Infarction

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Cerebral Infarction
Hematologic Agents
Physiological Effects of Drugs
Fibrinolytic Agents
Brain Diseases
Cerebrovascular Disorders
Fibrin Modulating Agents
Pathologic Processes
Aspirin
Sensory System Agents
Therapeutic Uses
Brain Ischemia
Cardiovascular Diseases

Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Ischemic Attack, Transient
Cyclooxygenase Inhibitors
Nervous System Diseases
Stroke
Vascular Diseases
Central Nervous System Diseases
Enzyme Inhibitors
Cardiovascular Agents
Ischemia
Pharmacologic Actions
Analgesics, Non-Narcotic
Clopidogrel
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on September 02, 2009