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

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ClinicalTrials.gov Identifier: NCT01103440
Recruitment Status : Completed
First Posted : April 14, 2010
Results First Posted : February 14, 2018
Last Update Posted : February 14, 2018
Sponsor:
Information provided by (Responsible Party):
Annapoorna Kini, Icahn School of Medicine at Mount Sinai

April 12, 2010
April 14, 2010
January 18, 2018
February 14, 2018
February 14, 2018
April 2007
June 2009   (Final data collection date for primary outcome measure)
Number of Participants With Elevation of Cardiac Enzyme [ Time Frame: 24 hours ]
Number of participants with peri-procedural biomarker elevation defined as any elevation above baseline of CK-MB or Tn-I within 24 hours after completion of the procedure.
Elevation of Cardiac Enzyme [ Time Frame: 24 hours ]
Complete list of historical versions of study NCT01103440 on ClinicalTrials.gov Archive Site
Number of Participants With Major Adverse Cardiac Event (MACE) [ Time Frame: 30 days ]
Number of participants with MACE which is any event of Death, MI, Stent Thrombosis, Urgent Revascularization, Bleeding. Major adverse cardiac events (MACE), defined as the composite of death, MI (CK-MB > 3 times normal), urgent revascularization and definite or probable stent thrombosis (ST) within 30 days. Stent thrombosis was defined according to the new academic research consortium definitions; 2) bleeding complications within 30 days. Major bleeding was defined as intracranial or intraocular bleeding or a drop in hemoglobin > 5 g/dL. Minor bleeding was defined as hemorrhage at the access site requiring intervention, hematoma with a diameter of at least 5 cm, a reduction in hemoglobin levels of at least 4 g/dL without an overt bleeding source or at least 3 g/dL with such a source, reoperation for bleeding or transfusion of a blood product.
Major Adverse Cardiac Event [ Time Frame: 30 days ]
Death, MI, Stent Thrombosis, Urgent Revascularization, Bleeding
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
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Same as current
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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01103440
GCO-07-0200
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Annapoorna Kini, Icahn School of Medicine at Mount Sinai
Icahn School of Medicine at Mount Sinai
Not Provided
Principal Investigator: Annapoorna S Kini, MD MRCP Icahn School of Medicine at Mount Sinai
Icahn School of Medicine at Mount Sinai
January 2018

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