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Aspirin Resistance and Percutaneous Coronary Intervention (PCI)

Information source: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Stable Angina

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

Phase: N/A

Status: Completed

Sponsored by: Icahn School of Medicine at Mount Sinai

Official(s) and/or principal investigator(s):
Annapoorna S Kini, MD MRCP, Principal Investigator, Affiliation: Icahn School of Medicine at Mount Sinai

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).

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Elevation of Cardiac Enzyme

Secondary outcome: Major Adverse Cardiac Event

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Mount Sinai Medical Center, New York, New York 10029, United States
Additional Information

Starting date: April 2007
Last updated: April 6, 2015

Page last updated: August 23, 2015

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