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

NCT00589862 | Withdrawn Phase 4

• 1 other identifier: 07-14622
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease

Keywords

Drug Eluting Stents; Clopidogrel Resistance; Aspirin Resistance

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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

• 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

Study Arms (1)

1

EXPERIMENTAL

Drug: Plavix (Clopidogrel)

Interventions

Plavix (Clopidogrel) DRUG

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

1

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• The last drug-eluting stent placed greater than 2 weeks prior
• Aspirin or Plavix (Clopidogrel) allergy or contraindication

Sponsors & Collaborators

• Creighton University: lead

Study Sites (1)

Creighton University Medical Center

Omaha, Nebraska, 68131, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Daniel Hilleman, PharmD

  Creighton University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 28, 2007
• First Posted: January 10, 2008
• Study Start: October 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: November 30, 2015

Record last verified: 2015-11

Locations

US (1)