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
  Purpose

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 Intervention
Stable Angina
Drug: Intravenous Glycoprotein inhibitor + ASA, Clopidogrel
Drug: Antiplatelet Therapy (ASA, Clopidogrel)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Elevation of Cardiac Enzyme [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Major Adverse Cardiac Event [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Death, MI, Stent Thrombosis, Urgent Revascularization, Bleeding


Enrollment: 36
Study Start Date: April 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01103440

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

No publications provided

Responsible Party: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01103440     History of Changes
Other Study ID Numbers: GCO-07-0200
Study First Received: April 12, 2010
Last Updated: March 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
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
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Clopidogrel
Ticlopidine
Krestin
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents
Adjuvants, Immunologic
Immunologic Factors
Antibiotics, Antineoplastic
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 22, 2014