Clinical Management of Antiplatelet Drug Resistance in Patients With Drug Eluting Coronary Stents

Coronary Artery Disease Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00589862
• Other study ID #: 07-14622
• Secondary ID: 07-14622
• Status: Withdrawn
• Phase: Phase 4
• First received: December 28, 2007
• Last updated: November 27, 2015
• Start date: October 2007
• Est. completion date: July 2008

Study information

• Verified date: November 2015
• Source: Creighton University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

It is recommended that patients who have drug-eluting stents placed in their coronary arteries take aspirin and Plavix (Clopidogrel) for at least a year. Patients who stop taking these antiplatelet drugs or who have resistance to the antiplatelet effects of these drugs are at a higher risk of clots occurring inside the stents which may result in a heart attack. At the present time, it is unknown if increasing the doses of the antiplatelet agents is effective in overcoming this resistance. The purpose of this project is to identify patients with antiplatelet drug resistance and to test whether an increase in the Plavix (Clopidogrel) dose overcomes antiplatelet drug resistance.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Required Coronary Artery Angioplasty with a drug-eluting stent deployment

Exclusion Criteria:

• The last drug-eluting stent placed greater than 2 weeks prior

• Aspirin or Plavix (Clopidogrel) allergy or contraindication

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Plavix (Clopidogrel)
150 mg tablet of Plavix (Clopidogrel) per day for 12 months if resistance is identified

Locations

Country	Name	City	State
United States	Creighton University Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Creighton University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to evaluate the frequency of aspirin and Plavix (Clopidogrel) resistance (as measured by a percent inhibition of platelet aggregation) in patients undergoing coronary drug-eluting stent deployment		3 month intervals up to 12 months	Yes
Secondary	to assess if a Plavix (Clopidogrel) dose increase in patients with resistance to both aspirin and Plavix (Clopidogrel) is effective in overcoming antiplatelet drug resistance		3 month intervals up to 12 months	Yes
Secondary	to evaluate the frequency of major adverse cardiovascular events in patients with and without antiplatelet resistance and following a dose increase in Plavix (Clopidogrel).		3 month intervals up to 12 months	Yes