NCT01499407

Randomized Trial of Standard vs ClearWay-infused Abciximab and Thrombectomy for Myocardial Infarction

A Randomized Trial to Compare Four Different Intracoronary Modalities to Reduce Thrombus Burden and Improve Microcirculatory Function in Patients With ST-elevation Myocardial Infarction: Rationale and Design of the COCTAIL II Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: CLI Foundation · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Subjects with ST-elevation myocardial infarction will be randomized, to one of the following: abciximab infusion with the ClearWay coronary catheter (C), standard abciximab infusion (A), thrombectomy followed by abciximab infusion with the ClearWay catheter (T+C), or thrombectomy followed by standard abciximab infusion (T+A). The primary objective is to demonstrate that abciximab infusion with the ClearWay catheter with or without manual thrombus aspiration (groups C or T+C) will result in a significant reduction of intra-stent thrombus formations when compared to intravenous or intracoronary abciximab with or without thrombectomy (groups A or T+A). The primary endpoint will be the number of cross sections with thrombus area \>10% immediately after stent implantation as assessed with OCT. Additional angiographic, ECG, and clinical endpoints will be collected and adjudicated. This trial is currently being registered at ClinicalTrials.gov.

Conditions

• ST-elevation Myocardial Infarction

Interventions

Type	Name	Description
DEVICE	ClearWay RX catheter
DRUG	Abciximab

Timeline

• Start date: 2011-12-01
• Primary completion: 2012-12-01
• Completion: 2013-04-01
• First posted: 2011-12-26
• Last updated: 2012-01-05

Locations

1 site across 1 country: Italy