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Completed

NCT Number: NCT01103440

Aspirin Resistance and Percutaneous Coronary Intervention (PCI)

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).

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Key information

Conditions

Stable Angina Angina Pectoris Angina, Stable Cardiovascular Diseases Chest Pain Death Heart Diseases Hemorrhage Myocardial Ischemia Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mount Sinai Medical Center

New York, 10029, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravenous Glycoprotein inhibitor + ASA, Clopidogrel

Drug

IV Glycoprotein IIb/IIIa inhibitor bolus intra procedurally

Other names: Cangrelor, Abciximab, Eptifibatide, Tirofiban

Antiplatelet Therapy (ASA, Clopidogrel)

Drug

Standard antiplatelet PCI treatment

Other names: Thienopyridines, Ticlopidine, Clopidogrel, Prasugrel

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study 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

Acronym: RESIST

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Apr 14, 2010
Registry last updated
Feb 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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