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
  Purpose

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.

Condition
Coronary Disease

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Platelet Reactivity After Cessation of Clopid in the Setting of Coronary Stent Implantation I: PRACTICE I

Resource links provided by NLM:


Further study details as provided by Medstar Research Institute:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: June 2007
Study Completion Date: February 2010
  Eligibility

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

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00684359

Locations
United States, District of Columbia
Ron Waksman, MD, Washington Hospital Center
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Medstar Research Institute
  More Information

No publications provided

Responsible Party: Ron Waksman, MD, MedStar Research Institute/Cardiovascular Research Institute
ClinicalTrials.gov Identifier: NCT00684359     History of Changes
Other Study ID Numbers: PRACTICE I
Study First Received: May 21, 2008
Last Updated: May 28, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Medstar Research Institute:
Patients having PCI with a drug eluting stent

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on April 17, 2014