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

• 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: Icahn School of Medicine at Mount Sinai
• Information provided by (Responsible Party): Annapoorna Kini, Icahn School of Medicine at Mount Sinai

Study Description

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 Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

Contacts and Locations

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

More Information

• Responsible Party: Annapoorna Kini, Professor, Icahn School of Medicine at Mount Sinai
• ClinicalTrials.gov Identifier: NCT01103440
• Other Study ID Numbers: GCO-07-0200
• First Posted: April 14, 2010
• 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; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; polysaccharide-K; Tirofiban; Ticlopidine; Abciximab; Clopidogrel; Prasugrel Hydrochloride; Cangrelor; Eptifibatide; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Anticoagulants; Fibrinolytic Agents; Fibrin Modulating Agents; Adjuvants, Immunologic; Immunologic Factors