Efficacy of Early Administration of Clotinab in Acute Myocardial Infarction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

786 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2009-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The ADMIRAL (Platelet glycoprotein IIb/IIIa inhibition with coronary stenting for acute myocardial infarction) study demonstrated that early administration of abciximab in patients with ST elevation acute myocardial infarction prior to PCI improves clinical outcomes but no specifically designed randomized study has addressed the issue of early upstream use of GP IIb/IIIa inhibitors in ST elevation acute myocardial infarction who are undergoing PCI, especially in the era of routine pretreatment with 600 mg of clopidogrel. Therefore, the objective of the randomized ECLAT-STEMI study was to assess the hypothesis that the early upstream use of Clotinab is a useful therapy in patients with ST elevation MI undergoing PCI compared to "provisional use", even after pretreatment with a 600-mg loading dose of clopidogrel.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Exploratory P2 Trial to Evaluate Efficacy and Safety of Clotinab® (Abciximab) in Acute MI Patients

NCT03087539

Acute Myocardial Infarction

UNKNOWN PHASE2

Intracoronary Bolus Only Compared With Intravenous Bolus and 12-hours Infusion of Abciximab in Non-ST Elevation Myocardial Infarction.

NCT01080638

Myocardial Infarction Angioplasty

UNKNOWN PHASE4

Evolocumab in STEMI

NCT06081803

ST Elevation Myocardial Infarction

ACTIVE_NOT_RECRUITING PHASE3

Pilot Study of IC14 (Atibuclimab), an Anti-CD14 Monoclonal Antibody, to Treat STEMI

NCT06678074

STEMI STEMI (ST Elevation MI) STEMI - ST Elevation Myocardial Infarction (MI) +1 more

RECRUITING PHASE1/PHASE2

Efficacy Of Eptifibatide Compared To Abciximab In Primary Percutaneous Coronary Intervention (PCI) For Acute ST Elevation Myocardial Infarction (STEMI)

NCT00426751

Infarction, Myocardial

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

It is well known that platelet-mediated thrombosis is account for the pathophysiology of acute coronary syndrome (ACS) (1,2). In the treatment of ACS, intravenous platelet glycoprotein (GP) IIb/IIIa receptor antagonists for platelet aggregation may reduce the risk of ischemic complications (3-7). Therefore, in the management of ACS, Platelet GP IIb/IIIa receptor inhibitors have been developed as a promising new therapy for the reduction of coronary events and the improvement of clinical outcomes.

Abciximab, one of platelet GP IIb/IIIa receptor blockers, was developed by Coller in 1985 and named as 7E3(8). Abciximab is a chimeric human monoclonal antibody and binds to platelet surface GP IIb/IIIa receptor competitively with adhesive molecules such as fibrinogen and von Willebrand factor, and blocks the final stage of platelet aggregation(9). The effect of Abciximab has been proved in many clinical trials such as the EPIC trial(9), EPILOG trial(10), TARGET(11) etc. The contribution of GP IIb/IIIa inhibition in ACS (Tirofiban) is shown in placebo-controlled trials in which upstream GP IIb/IIIa inhibition was initiated upon admission (12,13). Although these results are encouraging, there are few other data to support the use of upstream GP IIb/IIIa inhibitors. Moreover, according to the GUSTO-IV trial (14), the use of Abciximab was not recommended in the manner of upstream use. To evaluate the role of abciximab in conservatively treated non-ST-elevation ACS patients, the GUSTO-IV study randomized 7800 patients with non-ST-elevation ACS to receive either placebo or an Abciximab bolus (0.25 mg/kg) and 24-hour or 48-hour infusion(0.125 µg/kg/min). However, in fact, a trend was noted for potential harm with the higher abciximab dose. Even subgroup analyses including high-risk troponin-positive patients showed no benefit with either abciximab regimen (9.7% with placebo, 10.2% with 24-hour abciximab, 11.7% with 48-hour abciximab for death or MI at 30 days, P = NS). Because of these results, the majority of patients received abciximab relatively late, at the time of PCI in clinical practices.

However, the ADMIRAL study (3) demonstrated that early administration of abciximab in patients with ST elevation acute myocardial infarction prior to PCI improves clinical outcomes and also no specifically designed randomized study has addressed the issue of early upstream use of GP IIb/IIIa inhibitors in ST elevation acute myocardial infarction who are undergoing PCI, especially in the era of routine pretreatment with 600 mg of clopidogrel. Therefore, the objective of the randomized ECLAT-STEMI study was to assess the hypothesis that the early upstream use of Clotinab is a useful therapy in patients with ST elevation MI undergoing PCI compared to "provisional use", even after pretreatment with a 600-mg loading dose of clopidogrel.

The Clotinab, a product made in ISU ABXIS CO., LTD, was produced by inserting anti- platelet GP IIb/IIIa DNA into Chinese hamster's ovary cell. Since it contains identical active ingredient as ReoPro® on the domestic market, it is expected that the Clotinab has same efficacy to ReoPro® as a platelet GP IIb/IIIa receptor inhibitor. Recently, the Clotinab is shown to be safe and effective in preventing ischemic heart complications for high-risk patients who will undergo PCI.

2\. Study Protocol 2-1. Objectives: Randomized, controlled, single blind, multi-center trial To assess the hypothesis that the early upstream use of Clotinab is a useful therapy in patients with ST elevation myocardial infarction undergoing PCI compared to "provisional use", even after pretreatment with a 600-mg loading dose of clopidogrel.

2-2. Study Design: Efficacy of CLotinab in ST-elevation Acute myocardial infarction Trial - ST Elevation Myocardial Infarction (The ECLAT - STEMI study)

2-3. Study Endpoints:

1. Primary Endpoint: Efficacy To evaluate the effect of early upstream use of Clotinab (started at emergency room) co-administered with clopidogrel loading dose 600mg in STEMI

\- 30 Days MACCE (death, MI, TVR, cerebrovascular event)
2. Secondary Endpoint: Efficacy and Safety To evaluate the safety of early upstream use of Clotinab (started at emergency room) co-administered with clopidogrel loading dose 600mg in STEMI

* TIMI flow at before and after PCI
* Corrected TIMI frame count after PCI
* Procedural success (No reflow incidence)
* MACCE at 9 month
* Major bleeding event (According to TIMI criteria)
* 9 month Angiography Finding

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myocardial Infarction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Provisional use of Clotinab

Provisional use of clotinab

Group Type ACTIVE_COMPARATOR

Clotinab

Intervention Type DRUG

Clotinab: IV bolus 0.25 mg per Kg and a 12-hour IV infusion 0.125 μg per kg

Upstream use of clotinab

early upstream use of clotinab

Group Type EXPERIMENTAL

Clotinab

Intervention Type DRUG

Clotinab: IV bolus 0.25 mg per Kg and a 12-hour IV infusion 0.125 μg per kg

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Clotinab

Clotinab: IV bolus 0.25 mg per Kg and a 12-hour IV infusion 0.125 μg per kg

Intervention Type DRUG

Clotinab

Clotinab: IV bolus 0.25 mg per Kg and a 12-hour IV infusion 0.125 μg per kg

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Clotinab, Gp IIb/IIIa inhibitor Clotinab, Gp IIb/IIIa inhibitor

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. The patient must be at least 18-80 years of age.
2. The patient had the symptoms of acute myocardial infarction within 12 hours with ST segment elevation of more than 1 mm in at least two contiguous leads of EKG or new onset LBBB.
3. The patient or guardian agrees to the study protocol and provides informed, written consent.

Exclusion Criteria

1. Patients to whom PCI can not be undergone within 12 hours from receiving the study drug
2. Cardiogenic shock or symptomatic hypotension or sitting SBP \< 95 mmHg
3. The history of major surgery, trauma, retinal hemorrhage, significant gastrointestinal or genitourinary bleeding within recent 6 weeks;
4. History of cerebrovascular attack within two years, or cerebrovascular attack with a significant residual neurological deficit
5. Severe or malignant hypertension (= sitting SBP \> 180 mmHg and/or sitting DBP \> 105 mmHg)
6. The patients who require oral anticoagulants during the trial; patients who have been administrated oral anticoagulants within 7 days
7. The history or diagnosis of vasculitis; renal insufficiency (the level of serum creatinine is two times higher than the upper limit of normal of each center)
8. The patients who could not take anti-platelet drugs
9. The patients who might die of other disease than cardiac disease during the trial.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No