NCT01103440

Aspirin Resistance and Percutaneous Coronary Intervention (PCI)

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stable Angina

Interventions

Type	Name	Description
DRUG	Intravenous Glycoprotein inhibitor + ASA, Clopidogrel	IV Glycoprotein IIb/IIIa inhibitor bolus intra procedurally
DRUG	Antiplatelet Therapy (ASA, Clopidogrel)	Standard antiplatelet PCI treatment

Timeline

• Start date: 2007-04-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2010-04-14
• Last updated: 2018-02-14
• Results posted: 2018-02-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study