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Aspirin Resistance and Percutaneous Coronary Intervention (PCI) (RESIST)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01103440
First received: April 12, 2010
Last updated: March 7, 2012
Last verified: April 2010

April 12, 2010
March 7, 2012
April 2007
June 2009   (final data collection date for primary outcome measure)
Elevation of Cardiac Enzyme [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01103440 on ClinicalTrials.gov Archive Site
Major Adverse Cardiac Event [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Death, MI, Stent Thrombosis, Urgent Revascularization, Bleeding
Same as current
Not Provided
Not Provided
 
Aspirin Resistance and Percutaneous Coronary Intervention (PCI)
A Randomized, Pilot, Single-center Study, Investigator-Initiated Study to Look at an Aggressive Therapeutic Approach in Aspirin Resistant Patients Comparing to Standard for Patient Undergoing Percutaneous Coronary Intervention

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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Stable Angina
  • Drug: Intravenous Glycoprotein inhibitor + ASA, Clopidogrel
    IV Glycoprotein IIb/IIIa inhibitor bolus intra procedurally
    Other Names:
    • Cangrelor
    • Abciximab
    • Eptifibatide
    • Tirofiban
  • Drug: Antiplatelet Therapy (ASA, Clopidogrel)
    Standard antiplatelet PCI treatment
    Other Names:
    • Thienopyridines
    • Ticlopidine
    • Clopidogrel
    • Prasugrel
  • Conventional Strategy
    Patient receive 325 mg ASA orally and loading does of 600mg Clopidogrel at time of procedure
    Intervention: Drug: Antiplatelet Therapy (ASA, Clopidogrel)
  • Active Comparator: 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
    Intervention: Drug: Intravenous Glycoprotein inhibitor + ASA, Clopidogrel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
June 2009
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01103440
GCO-07-0200
Yes
Mount Sinai School of Medicine
Mount Sinai School of Medicine
Not Provided
Principal Investigator: Annapoorna S Kini, MD MRCP Mount Sinai School of Medicine
Mount Sinai School of Medicine
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP