- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00684359
Platelet Reactivity After Cessation of Clopid in the Setting of Coronary Stent Implantation I: PRACTICE I (PRACTICE I)
May 28, 2010 updated by: Medstar Health Research Institute
Single center randomized parallel group study to determine if:
- there is a temporary increase in platelet reactivity after abrupt discontinuation of clopidogrel due to a potential rebound phenomenon.
- the effect of sudden discontinuation of clopidogrel 6 months post coronary angioplasty with adjunct drug eluting stent implantation compared to 12 month continuation of clopidogrel on platelet reactivity. And the association with MACE up to 12 months post coronary angioplasty.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Anticipated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
District of Columbia
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Washington, District of Columbia, United States, 20010
- Ron Waksman, MD, Washington Hospital Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients, male or female, > 18 years of age; who are scheduled for an elective PCI with a drug eluting stent; willing to return for all required follow up visit and live/work within a 60 mile radius of the Washington Hospital Center.
Description
Inclusion Criteria:
- Patients, male or female, > 18 years of age,
- Patients who are scheduled for an elective PCI with a drug eluting stent
- Patients willing to return for all required follow up visits.
- Patients live/work within a 60 mile radius of the Washington Hospital Center.
Exclusion Criteria:
- Patient has experienced an acute myocardial infarction within the preceding 48 hours of the subsequent angioplasty.
- Unprotected left main coronary disease with >50% stenosis;
- Patients with renal failure requiring dialysis;
- Patients with a documented ejection fraction < 30 percent at the time of subsequent PCI;
- Patient with a life expectancy less than 12 months or malignancy.
- Known allergies to aspirin or clopidogrel bisulfate (PlavixR) and that cannot be medically managed;
- Planned surgery or other indication for requiring the cessation of clopidogrel within 12 months of PCI;
- Any significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study.
- Patients with known history of bleeding diathesis;
- Prothrombin time >1.5 times control; coumadin therapy
- Platelet count <100 000/mm3;
- Hematocrit <25%;
- Creatinine >4.0 mg/dL;
- Thienopyridine use within 5 days of enrollment
- Glycoprotein (GP) IIb/IIIa use within 8 hours of enrollment or any indication were the operator will require GP IIb/IIIa inhibitor use during the hospitalization.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine if there is a temporary increase in platelet reactivity after abrupt discontinuation of clopidogrel due to a potential rebound phenomenon
Time Frame: Up to 12 months
|
Up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine what the effect of sudden discontinuation of clopidogrel 6 months post coronary angioplasty with adjunct drug eluting stent implantation compared to 12 month continuation of clopidogrel on platelet reactivity.
Time Frame: up to 12 months
|
up to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Study Completion (Actual)
February 1, 2010
Study Registration Dates
First Submitted
May 21, 2008
First Submitted That Met QC Criteria
May 23, 2008
First Posted (Estimate)
May 26, 2008
Study Record Updates
Last Update Posted (Estimate)
May 31, 2010
Last Update Submitted That Met QC Criteria
May 28, 2010
Last Verified
May 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRACTICE I
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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