Randomized Trial of Standard vs ClearWay-infused Abciximab and Thrombectomy for Myocardial Infarction (COCTAIL II)
Primary Purpose
ST-elevation Myocardial Infarction
Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
ClearWay RX catheter
Abciximab
Sponsored by
About this trial
This is an interventional treatment trial for ST-elevation Myocardial Infarction
Eligibility 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.
Sites / Locations
- A. O. S. Giovanni AddolorataRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Experimental
Active Comparator
Arm Label
Standard abciximab bolus
ClearWay-infused abciximab
Thrombectomy plus ClearWay-infused abciximab
Thrombectomy plus standard abciximab bolus
Arm Description
Outcomes
Primary Outcome Measures
Thrombus area
The primary endpoint of this trial will be the post-procedural number of cross sections with thrombus area >10% at optical coherence tomography.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01499407
Brief Title
Randomized Trial of Standard vs ClearWay-infused Abciximab and Thrombectomy for Myocardial Infarction
Acronym
COCTAIL II
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 Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
December 2011 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
April 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CLI Foundation
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST-elevation Myocardial Infarction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard abciximab bolus
Arm Type
Active Comparator
Arm Title
ClearWay-infused abciximab
Arm Type
Experimental
Arm Title
Thrombectomy plus ClearWay-infused abciximab
Arm Type
Experimental
Arm Title
Thrombectomy plus standard abciximab bolus
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
ClearWay RX catheter
Intervention Type
Drug
Intervention Name(s)
Abciximab
Primary Outcome Measure Information:
Title
Thrombus area
Description
The primary endpoint of this trial will be the post-procedural number of cross sections with thrombus area >10% at optical coherence tomography.
Time Frame
1 week
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francesco Prati, MD
Email
fprati@hsangiovanni.roma.it
Facility Information:
Facility Name
A. O. S. Giovanni Addolorata
City
Rome
State/Province
RM
ZIP/Postal Code
00184
Country
Italy
Individual Site Status
Recruiting
12. IPD Sharing Statement
Citations:
PubMed Identifier
22929568
Citation
Prati F, Di Vito L, Ramazzotti V, Imola F, Pawlowski T, Materia L, Tavazzi L, Biondi-Zoccai G, Albertucci M. Randomized trial of standard versus ClearWay-infused abciximab and thrombectomy in myocardial infarction: rationale and design of the COCTAIL II study. J Cardiovasc Med (Hagerstown). 2013 May;14(5):364-71. doi: 10.2459/JCM.0b013e3283586fee.
Results Reference
derived
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Randomized Trial of Standard vs ClearWay-infused Abciximab and Thrombectomy for Myocardial Infarction
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