Prospective, randomized and controlled clinical trial comparing i.v. bolus application of Abciximab to i.c.application of Abciximab during primary PCU in patients with acute ST-elevation myocardial infarction - Abciximab-STEMI

Phase 1

• Conditions: ST-elevation myocardial infarction; MedDRA version: 9.1Level: LLTClassification code 10000891Term: Acute myocardial infarction

• Registration Number: EUCTR2007-007864-63-DE
• Lead Sponsor: niversity of Leipzig

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-08
• Study Completion: 2012-06-11
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2065

Inclusion Criteria

1) >= 18 years of age

2) ST-elevation myocardial infarction, characterized by:

a)Clinical symptoms:
Angina pectoris < 12 hours and
Persistent angina > 30 minutes

b) ECG-criteria in 12-lead ECG:
ST-segment elevation > 1mm in = 2 extremity leads and / or
ST-segment elevation > 2mm in = 2 adjacent precordial leads
3) written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1)Known drug hypersensitivity to Abciximab, other components of the trial medication or murine monoclonal antibodies
2)Known drug hypersensitivity to ASS or heparin
3)Active peptic ulcus ventriculi or duodeni
4)Major surgical interventions, lithotripsy, intracranial / intraspinal interventions or puncture of a not sufficiently compressible vessel less than eight weeks before start of trial
5)Intracranial tumors
6)Active internal bleeding
7)Cerebrovascular complications less than 2 years befor start of trial
8)Known coagulation defect or thrombocytopenia
9)Arteriovenous malformations or aneurysm
10)Severe liver or renal insufficiency (creatinin clearence < 30 ml/min)
11)Uncontrolled hypertension, hypertensive retinopathy
12)Vasculitis
13)Previous thrombolysis (less than 12 hrs ago)
14)Lacking compliance
15) Pregnant or nursing women
16) Fertile female patients (< 2 years post their last menstruation) without using appropriate contraception (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner) during trial participation
17)Participation in another interventional trial

Additional exclusion criteria for the MRT substudy:

1) Severe claustrophobia
2) Hemodynamic instability
3) Pacemaker or internal cardioverter defibrillator (ICD)
4) Metallic cerebral or intracranial implants
5) Known frug hypersensitivity to Gadolinium

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To examine whether intracoronary abciximab bolus application with subsequent 12 hour intravenous infusion in addition to primary percutaneous coronary intervention is beneficial for patients with STEMI in comparison to standard i.v. bolus application with respect to 90-day mortality, reinfarction and new congestive heart failure;Secondary Objective: Key secondary endpoint(s) evaluating the efficacy of the trial therapy: ST-segment resolution 90 minute ECG; TIMI-flow post PCI; indirect infarct size by enzyme release; individual clinical endpoints;Primary end point(s): Combined clinical endpoint at 90 days consisting of mortality, reinfarction, and new congestive heart failure.