Aspirin Resistance and Percutaneous Coronary Intervention (PCI)

Stable Angina Clinical Trial

— RESIST  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01103440
• Other study ID #: GCO-07-0200
• Status: Completed
• Phase: Phase 2
• First received: April 12, 2010
• Last updated: January 18, 2018
• Start date: April 2007
• Est. completion date: June 2009

Study information

• Verified date: January 2018
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Angina, Stable
• Stable Angina

Intervention

Drug:
• Intravenous Glycoprotein inhibitor + ASA, Clopidogrel
IV Glycoprotein IIb/IIIa inhibitor bolus intra procedurally
• Antiplatelet Therapy (ASA, Clopidogrel)
Standard antiplatelet PCI treatment

Locations

Country	Name	City	State
United States	Mount Sinai Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants With Major Adverse Cardiac Event (MACE)	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.	30 days