ST-elevation Myocardial InfarctionPhase 4COCTAIL IINCT01499407
Randomized Trial of Standard vs ClearWay-infused Abciximab and Thrombectomy for Myocardial Infarction
A Phase 4 study testing ClearWay RX catheter and Abciximab in people with ST-elevation Myocardial Infarction, run by CLI Foundation at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ST-elevation Myocardial Infarction
- What is being tested?
- ClearWay RX catheter and Abciximab
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2011to Apr 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
Francesco Prati, MD contact
Italy1 site, 1 recruiting
- Recruiting
A. O. S. Giovanni Addolorata
Rome, RM, 00184
About this study
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
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
- Being tested
- ClearWay RX catheter, Abciximab
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClearWay RX catheterDevice
AbciximabDrug
| Study group | Role | What they receive |
|---|---|---|
| Standard abciximab bolus | Active comparator | Not described Receives: Drug: Abciximab |
| ClearWay-infused abciximab | Experimental | Not described Receives: Device: ClearWay RX catheter |
| Thrombectomy plus ClearWay-infused abciximab | Experimental | Not described Receives: Device: ClearWay RX catheter |
| Thrombectomy plus standard abciximab bolus | Active comparator | Not described Receives: Drug: Abciximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionDec 2012 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ST-elevation Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CLI Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Prati, CLI Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01499407
- Sponsor's protocol ID
- COCTAIL II
- Acronym
- COCTAIL II
- Status last verified
- Jan 2012
- First submitted
- 21 Dec 2011
- Last updated
- 5 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22929568
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01499407
- Acronym / sponsor ID
- COCTAIL II / COCTAIL II
- Conditions
- ST-elevation Myocardial Infarction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- CLI FoundationUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 26 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (17 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClearWay RX catheter | Device | ClearWay-infused abciximab, Thrombectomy plus ClearWay-infused abciximab |
| Abciximab | Drug | Standard abciximab bolus, Thrombectomy plus standard abciximab bolus |
Primary outcome
Thrombus area
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2012.
- Derived from this study: PubMed 22929568Prati 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Prati, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ClearWay RX catheter and Abciximab in people with ST-elevation Myocardial Infarction, run by CLI Foundation at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesco Prati, MD (fprati@hsangiovanni.roma.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thrombus area (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01499407, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2012.