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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

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).

Condition or disease Intervention/treatment Phase
Stable Angina Drug: Intravenous Glycoprotein inhibitor + ASA, Clopidogrel Drug: Antiplatelet Therapy (ASA, Clopidogrel) Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2007
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Conventional Strategy
Patient receive 325 mg ASA orally and loading does of 600mg Clopidogrel at time of procedure
Drug: Antiplatelet Therapy (ASA, Clopidogrel)
Standard antiplatelet PCI treatment
Other Names:
  • Thienopyridines
  • Ticlopidine
  • Clopidogrel
  • Prasugrel
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
Drug: Intravenous Glycoprotein inhibitor + ASA, Clopidogrel
IV Glycoprotein IIb/IIIa inhibitor bolus intra procedurally
Other Names:
  • Cangrelor
  • Abciximab
  • Eptifibatide
  • Tirofiban



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01103440


Locations
United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
Principal Investigator: Annapoorna S Kini, MD MRCP Icahn School of Medicine at Mount Sinai

Responsible Party: Annapoorna Kini, Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01103440     History of Changes
Other Study ID Numbers: GCO-07-0200
First Posted: April 14, 2010    Key Record Dates
Results First Posted: February 14, 2018
Last Update Posted: February 14, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Annapoorna Kini, Icahn School of Medicine at Mount Sinai:
Major Adverse Cardiovascular Event
MACE
Death
MI
CK MB greater 3x Normal
Urgent Revascularization
Stent Thrombosis
Bleeding

Additional relevant MeSH terms:
Angina, Stable
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Signs and Symptoms
Aspirin
Ticlopidine
Clopidogrel
Krestin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics