Status:
UNKNOWN
Randomized Trial of Standard vs ClearWay-infused Abciximab and Thrombectomy for Myocardial Infarction
Lead Sponsor:
CLI Foundation
Conditions:
ST-elevation Myocardial Infarction
Eligibility:
All Genders
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2013
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT01499407
Start Date
December 1 2011
End Date
April 1 2013
Last Update
January 5 2012
Active Locations (1)
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1
A. O. S. Giovanni Addolorata
Rome, RM, Italy, 00184