Aspirin Resistance and Percutaneous Coronary Intervention (PCI)

NCT ID: NCT01103440

Last Updated: 2018-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2009-06-30

Brief Summary

The objective of this study is to evaluate if aggressive antiplatelet therapy would reduce ischemic events in aspirin (ASA) resistant patients after percutaneous coronary intervention (PCI).

Detailed Description

This is the first US based randomized double blinded prospective study using triple antiplatelet therapy and double dose plavix maintenance dose in aspirin resistant patients undergoing elective PCI through femoral access. The primary outcome of this study is an elevation of cardiac enzymes within 24 hours after the PCI with a secondary outcome of a composite of major adverse cardiac events of death, MI, stent thrombosis and urgent revascularization and bleeding up to 30 days.

Conditions

Stable Angina

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional Strategy

Patient receive 325 mg ASA orally and loading does of 600mg Clopidogrel at time of procedure

Group Type: OTHER

Antiplatelet Therapy (ASA, Clopidogrel)

Intervention Type: DRUG

Standard antiplatelet PCI treatment

Aggressive Strategy

Patient receive 325mg ASA orally and loading does of 600mg Clopidogrel at time of procedure with addition of IV GP IIb/IIIa inhibitor bolus intra procedurally

Group Type: ACTIVE_COMPARATOR

Intravenous Glycoprotein inhibitor + ASA, Clopidogrel

Intervention Type: DRUG

IV Glycoprotein IIb/IIIa inhibitor bolus intra procedurally

Interventions

Intravenous Glycoprotein inhibitor + ASA, Clopidogrel

IV Glycoprotein IIb/IIIa inhibitor bolus intra procedurally

Intervention Type: DRUG

Antiplatelet Therapy (ASA, Clopidogrel)

Standard antiplatelet PCI treatment

Intervention Type: DRUG

Other Intervention Names

Cangrelor; Abciximab; Eptifibatide; Tirofiban; Thienopyridines; Ticlopidine; Clopidogrel; Prasugrel

Eligibility Criteria

Inclusion Criteria

• Age older than 18 years
• Scheduled for elective or ad-hos PCI
• Aspirin use daily for greater or equal to one week
• Aspirin resistant (ARU greater than or equal to 550 on Verify Now-ASA

Exclusion Criteria

• Pre-procedural elevation of cardiac biomarkers (CK-MB greater or equal to 10.4ng/dl or Tnl greater or equal to 0.4ng/dl
• administration of any GP IIb/IIIa inhibitor, anticoagulation or lytic therapy in the previous 30 days
• Ongoing bleeding or bleeding diathesis, contraindications for anticoagulation or increased bleeding risk or history of bleeding in the last eight weeks
• Previous stroke or transient ischemic attack or any intracranial pathology in the last six months, major surgery or trauma within the previous six weeks
• Platelet count less than hundred thousand per cubic millimeter or hematocrit <33% or hemoglobin <11 g per deciliter
• Subjects who received full dose low molecular weight heparin within six hours prior to randomization
• Allergy or intolerance to any of the study drugs or the presence of any serious comorbidity with life expectancy of ≤1year
• Scheduled for saphenous vein graft intervention, chronic total occlusions or with impaired renal function (eGFR<60ml/min) or patients who were taking anticoagulants or antiplatelet agents other than aspirin and clopidogrel or nonsteroidal anti-inflammatory drugs within two weeks before the PCI procedure

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Annapoorna Kini

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Annapoorna S Kini, MD MRCP

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Mount Sinai Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

GCO-07-0200

Identifier Type: -

Identifier Source: org_study_id