Clinical trial NCT01103440: Aspirin Resistance and Percutaneous Coronary Intervention (PCI)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stable Angina
Keywords: Major Adverse Cardiovascular Event
MACE
Death
MI
CK MB greater 3x Normal
Urgent Revascularization
Stent Thrombosis
Bleeding
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2010-04-14
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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 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

Primary outcomes:
measure: Number of Participants With Elevation of Cardiac Enzyme
timeFrame: 24 hours
Secondary outcomes:
measure: Number of Participants With Major Adverse Cardiac Event (MACE)
timeFrame: 30 days
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Annapoorna S Kini, MD MRCP
role: PRINCIPAL_INVESTIGATOR
References: