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

NCT01499407 | Unknown Phase 4

• 1 other identifier: COCTAIL II
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

ST-elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• 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.

  1 week

Study Arms (4)

Standard abciximab bolus

ACTIVE COMPARATOR

Drug: Abciximab

ClearWay-infused abciximab

EXPERIMENTAL

Device: ClearWay RX catheter

Thrombectomy plus ClearWay-infused abciximab

EXPERIMENTAL

Device: ClearWay RX catheter

Thrombectomy plus standard abciximab bolus

ACTIVE COMPARATOR

Drug: Abciximab

Interventions

ClearWay RX catheter DEVICE

ClearWay-infused abciximab; Thrombectomy plus ClearWay-infused abciximab

Abciximab DRUG

Standard abciximab bolus; Thrombectomy plus standard abciximab bolus

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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),

Sponsors & Collaborators

• CLI Foundation: lead

Study Sites (1)

A. O. S. Giovanni Addolorata

Rome, RM, 00184, Italy

RECRUITING

Related Publications (1)

• 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.

  PMID: 22929568 DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Abciximab

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Central Study Contacts

Francesco Prati, MD

CONTACT

fprati@hsangiovanni.roma.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: De.

Study Record Dates

• First Submitted: December 21, 2011
• First Posted: December 26, 2011
• Study Start: December 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: April 1, 2013
• Last Updated: January 5, 2012

Record last verified: 2012-01

Locations

IT (1)