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

Sponsor
CLI Foundation (Other)
Overall Status
Unknown status
CT.gov ID
NCT01499407
Collaborator
(none)
128
Enrollment
1
Location
4
Arms
16
Duration (Months)
8
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
128 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Dec 1, 2011
Anticipated Primary Completion Date :
Dec 1, 2012
Anticipated Study Completion Date :
Apr 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Standard abciximab bolus

Drug: Abciximab
Experimental: ClearWay-infused abciximab

Device: ClearWay RX catheter
Experimental: Thrombectomy plus ClearWay-infused abciximab

Device: ClearWay RX catheter
Active Comparator: Thrombectomy plus standard abciximab bolus

Drug: Abciximab

Outcome Measures

Primary Outcome Measures

  1. Thrombus area [1 week]

    The primary endpoint of this trial will be the post-procedural number of cross sections with thrombus area >10% at optical coherence tomography.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • ischemic symptoms must be present at rest and last for at least 10 minutes,

  • within 6 hours from onset of chest pain,

  • ECG changes will be persistent ST-segment elevation or new-onset left bundle branch block,

  • cardiac markers can be either in the normal range or elevated (troponin I or T and/or creatine kinase-myocardial band upper limit of normal for the local laboratory assay),

  • coronary angiogram must be obtained within 6 hours from onset of symptom,

  • the culprit artery must be identified in a native vessel and must show a significant lesion indicative of local thrombosis with TIMI flow 0-2

  • patients must have signed the informed consent form prior to performance of trial-related procedures.

Exclusion Criteria:

  • baseline TIMI flow 3,

  • tortuosity of coronary vessels that may prevent negotiation of target lesions with the devices that are required by the protocol,

  • myocardial ischemia precipitated by a condition other than atherosclerotic coronary artery disease (e.g. arrhythmia, severe anemia, hypoxia, thyrotoxicosis, cocaine, severe valvular disease or hypotension),

  • use of a fibrinolytic agent within 14 days prior to randomization,

  • use of abciximab or any other glycoprotein IIb/IIIa inhibitor within 30 days prior to randomization,

  • suspected active internal bleeding or history of hemorrhahagic diathesis,

  • major surgery, biopsy of a parenchymal organ, eye surgery, or serious trauma within 6 weeks prior to randomization,

  • gastrointestinal or genitourinary bleeding of clinical significance within 6 weeks prior to randomization,

  • history of cerebrovascular accident (CVA) or transient ischemic attack within the previous 2 years or any CVA with a residual neurological deficit,

  • administration of oral anticoagulants within 7 days prior to randomization unless prothrombin time ≤1.2 times control (or international normalized ratio ≤1.4),

  • ongoing treatment with oral anticoagulant,

  • known current platelet count less than 100.000 cells/µL,

  • prior known intracranial neoplasm, arteriovenous malformation, aneurysm, or aneurysm repair,

  • known allergy to abciximab or other murine proteins,

  • known impaired renal function (estimated glomerular filtration rate <60 mL/min),

  • coexistent condition associated with a limited life expectancy (e.g. advanced cancer),

  • participation in any phase of another clinical research trial involving the evaluation of another investigational drug or device within 30 days prior to randomization, known positive pregnancy test for women of childbearing age.

Contacts and Locations

Locations

Site City State Country Postal Code
1 A. O. S. Giovanni Addolorata Rome RM Italy 00184

Sponsors and Collaborators

  • CLI Foundation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Francesco Prati, De., CLI Foundation
ClinicalTrials.gov Identifier:
NCT01499407
Other Study ID Numbers:
  • COCTAIL II
First Posted:
Dec 26, 2011
Last Update Posted:
Jan 5, 2012
Last Verified:
Jan 1, 2012
Additional relevant MeSH terms:
Myocardial Infarction
ST Elevation Myocardial Infarction
Infarction
Abciximab

Study Results

No Results Posted as of Jan 5, 2012