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OpenTrials
Completed

NCT Number: NCT00684359

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ron Waksman, MD, Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Medstar Health Research Institute

Other

Registry information

Acronym: PRACTICE I

Important dates

Study start
2007
Study completion
2010
First posted
May 26, 2008
Registry last updated
May 31, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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