Platelet Reactivity After Cessation of Clopid in the Setting of Coronary Stent Implantation I: PRACTICE I

This study has been completed.
Sponsor:
Information provided by:
Medstar Research Institute
ClinicalTrials.gov Identifier:
NCT00684359
First received: May 21, 2008
Last updated: May 28, 2010
Last verified: May 2010

May 21, 2008
May 28, 2010
June 2007
Not Provided
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00684359 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Platelet Reactivity After Cessation of Clopid in the Setting of Coronary Stent Implantation I: PRACTICE I
Platelet Reactivity After Cessation of Clopid in the Setting of Coronary Stent Implantation I: PRACTICE I

Single center randomized parallel group study to determine if:

  1. there is a temporary increase in platelet reactivity after abrupt discontinuation of clopidogrel due to a potential rebound phenomenon.
  2. 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.
Not Provided
Observational
Time Perspective: Retrospective
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Non-Probability Sample

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.

Coronary Disease
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
February 2010
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00684359
PRACTICE I
Yes
Ron Waksman, MD, MedStar Research Institute/Cardiovascular Research Institute
Medstar Research Institute
Not Provided
Not Provided
Medstar Research Institute
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP