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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by CLI Foundation.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Francesco Prati, CLI Foundation
ClinicalTrials.gov Identifier:
NCT01499407
First received: December 21, 2011
Last updated: January 2, 2012
Last verified: January 2012
  Purpose

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 Intervention Phase
ST-elevation Myocardial Infarction
Device: ClearWay RX catheter
Drug: Abciximab
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by CLI Foundation:

Primary Outcome Measures:
  • Thrombus area [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
    The primary endpoint of this trial will be the post-procedural number of cross sections with thrombus area >10% at optical coherence tomography.


Estimated Enrollment: 128
Study Start Date: December 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01499407

Contacts
Contact: Francesco Prati, MD fprati@hsangiovanni.roma.it

Locations
Italy
A. O. S. Giovanni Addolorata Recruiting
Rome, RM, Italy, 00184
Sponsors and Collaborators
CLI Foundation
  More Information

No publications provided by CLI Foundation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Francesco Prati, De., CLI Foundation
ClinicalTrials.gov Identifier: NCT01499407     History of Changes
Other Study ID Numbers: COCTAIL II
Study First Received: December 21, 2011
Last Updated: January 2, 2012
Health Authority: Italy: Ministero della Salute

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Abciximab
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Anticoagulants

ClinicalTrials.gov processed this record on July 24, 2014