- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01103440
Aspirin Resistance and Percutaneous Coronary Intervention (PCI) (RESIST)
January 18, 2018 updated by: Annapoorna Kini, Icahn School of Medicine at Mount Sinai
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
36
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10029
- Mount Sinai Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Conventional Strategy
Patient receive 325 mg ASA orally and loading does of 600mg Clopidogrel at time of procedure
|
Standard antiplatelet PCI treatment
Other Names:
|
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
|
IV Glycoprotein IIb/IIIa inhibitor bolus intra procedurally
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Annapoorna S Kini, MD MRCP, Icahn School of Medicine at Mount Sinai
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2007
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
April 12, 2010
First Submitted That Met QC Criteria
April 13, 2010
First Posted (Estimate)
April 14, 2010
Study Record Updates
Last Update Posted (Actual)
February 14, 2018
Last Update Submitted That Met QC Criteria
January 18, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Pain
- Neurologic Manifestations
- Chest Pain
- Angina Pectoris
- Angina, Stable
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Purinergic P2Y Receptor Antagonists
- Purinergic P2 Receptor Antagonists
- Purinergic Antagonists
- Purinergic Agents
- Antineoplastic Agents
- Immunologic Factors
- Protective Agents
- Cytochrome P-450 Enzyme Inhibitors
- Adjuvants, Immunologic
- Antibiotics, Antineoplastic
- Anticoagulants
- Interferon Inducers
- Radiation-Protective Agents
- Cytochrome P-450 CYP2C19 Inhibitors
- Clopidogrel
- Tirofiban
- Prasugrel Hydrochloride
- Cangrelor
- Abciximab
- Eptifibatide
- polysaccharide-K
- Ticlopidine
Other Study ID Numbers
- GCO-07-0200
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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