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

Coronary Disease Clinical Trial

— PRACTICE I  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00684359
• Other study ID #: PRACTICE I
• Status: Completed
• Phase: N/A
• First received: May 21, 2008
• Last updated: May 28, 2010
• Start date: June 2007
• Est. completion date: February 2010

Study information

• Verified date: May 2010
• Source: Medstar Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease

Locations

Country	Name	City	State
United States	Ron Waksman, MD, Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Medstar Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes