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

NCT00684359 | Completed DMC

• 1 other identifier: PRACTICE I
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Single center randomized parallel group study to determine if:

1. 1.there is a temporary increase in platelet reactivity after abrupt discontinuation of clopidogrel due to a potential rebound phenomenon.
2. 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.

Conditions

Coronary Disease

Keywords

Patients having PCI with a drug eluting stent

Outcome Measures

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

  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.

  up to 12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medstar Health Research Institute: lead

Study Sites (1)

Ron Waksman, MD, Washington Hospital Center

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

Location

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 21, 2008
• First Posted: May 26, 2008
• Study Start: June 1, 2007
• Study Completion: February 1, 2010
• Last Updated: May 31, 2010

Record last verified: 2010-05

Locations

US (1)