Aspirin Resistance and Percutaneous Coronary Intervention (PCI)

NCT01103440 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: GCO-07-0200
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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).

Conditions

Stable Angina

Keywords

Major Adverse Cardiovascular Event; MACE; Death; MI; CK MB greater 3x Normal; Urgent Revascularization; Stent Thrombosis; Bleeding

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Elevation of Cardiac Enzyme

  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 Outcomes (1)

• Number of Participants With Major Adverse Cardiac Event (MACE)

  30 days

Study Arms (2)

Conventional Strategy

OTHER

Patient receive 325 mg ASA orally and loading does of 600mg Clopidogrel at time of procedure

Drug: Antiplatelet Therapy (ASA, Clopidogrel)

Aggressive Strategy

ACTIVE COMPARATOR

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

Interventions

Intravenous Glycoprotein inhibitor + ASA, Clopidogrel DRUG

IV Glycoprotein IIb/IIIa inhibitor bolus intra procedurally

Also known as: Cangrelor, Abciximab, Eptifibatide, Tirofiban

Aggressive Strategy

Antiplatelet Therapy (ASA, Clopidogrel) DRUG

Standard antiplatelet PCI treatment

Also known as: Thienopyridines, Ticlopidine, Clopidogrel, Prasugrel

Conventional Strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Angina, Stable; Death; Hemorrhage

Interventions

Clopidogrel; cangrelor; Abciximab; Eptifibatide; Tirofiban; Thienopyridines; Ticlopidine; Prasugrel Hydrochloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Peptides, Cyclic; Tyrosine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Piperazines

Limitations and Caveats

Small pilot study with a limited sample size and not powered to detect differences in individual ischemic endpoints. Study does not delineate an optimal dose of aspirin. Antiplatelet effect of aspirin may fluctuate in patients at the same dosage.

Results Point of Contact

• Title: Dr. Annapoorna S Kini
• Organization: Icahn School of Medicine at Mount Sinai

Annapoorna.Kini@mountsinai.org

(212) 241-4181

Study Officials

• Annapoorna S Kini, MD MRCP

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 12, 2010
• First Posted: April 14, 2010
• Study Start: April 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: February 14, 2018
• Results First Posted: February 14, 2018

Record last verified: 2018-01

Locations

US (1)