Last updated: 11/03/2018 09:17:03
Efficacy Of Eptifibatide Compared To Abciximab In Primary Percutaneous Coronary Intervention (PCI) For Acute ST Elevation Myocardial Infarction (STEMI)
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Eptifibatide versus Abciximab in primary PCI for acute ST elevation myocardial infarction
Trial description: Multinational, multicentre, randomised, prospective, open, parallel group study directly comparing two glycoprotein-IIb/IIIa inhibitors, abciximab and eptifibatide, added early to standard treatment before primary PCI of STEMI patients with respect to effect on sum-ST-resolution after 60 minutes post-procedure and other measures of myocardial reperfusion
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Number of participants with complete sum ST resolution (STR) 60 minutes (min) after percutaneous coronary intervention (PCI) (Per Protocol Population)
Timeframe: Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)
Number of participants with complete sum ST resolution (STR) 60 min after percutaneous coronary intervention (PCI) (Intent-to-Treat Population)
Timeframe: Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)
Secondary outcomes:
Number of participants with complete or partial sum ST resolution (STR) 60 min after PCI
Timeframe: Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)
Number of participants with complete single lead ST resolution (STR) 60 min after PCI
Timeframe: Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)
Mean change from baseline in the sum ST resolution 60 min after PCI
Timeframe: Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)
Mean change from baseline in single lead ST resolution (STR) 60 min after PCI
Timeframe: Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)
Mean change from baseline in the sum ST resolution (STR) before PCI
Timeframe: Baseline (ECG I) and immediately prior to PCI (ECG II)
Mean maximum ST deviation existing (Max STE) 60 min after PCI
Timeframe: 60 min +/- 15 min after PCI (ECG III)
Number of Participants with the Indicated Patency of infarcted vessels according to thrombolysis in myocardial infarction (TIMI) classification before PCI
Timeframe: immediately before PCI
Number of participants with TIMI 3 patency of infarcted vessels following PCI
Timeframe: after PCI
Mean number of corrected TIMI frame counts (cTIMI) following PCI
Timeframe: after PCI
Number of participants with the indicated myocardial blush grade (TIMI myocardial perfusion grade [TMPG]) after PCI
Timeframe: after PCI
Combined endpoint: Number of Participants with Events of death, re-myocardial infarction (MI), and urgent target vessel revascularisation (UTVR)
Timeframe: Day 7 or hospital discharge; Day 30 after index-MI
Number of participants who died, and/or experienced re-MI and UTVR (individually counted)
Timeframe: Day 7 or hospital discharge; Day 30 after index-MI
Number of participants who experienced stroke or major bleeding complications
Timeframe: Day 7 or hospital discharge; Day 30 after index-MI
Number of participants who died and or experienced re-MI until 6 months after PCI
Timeframe: until 6 Month (Day 180) after index-MI
Number of participants with heart failure until 6 months after PCI
Timeframe: until 6 Months (Day 180) after index-MI
Number of participants with major bleedings (TIMI classification)
Timeframe: Day 7 or hospital discharge; Day 30 after index-MI
Number of participants with minor bleedings (TIMI classification)
Timeframe: Day 7 or hospital discharge; Day 30 after index-MI
Mean duration of stay in the ward
Timeframe: until 6 months after index-MI
Interventions:
Drug: Abciximab
Drug: Eptifibatide
Enrollment:
429
Observational study model:
Not applicable
Primary completion date:
2007-17-12
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Infarction, Myocardial
Product
eptifibatide
Collaborators
Not applicable
Study date(s)
October 2006 to December 2007
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Women must be postmenopausal (i.e.12 months without menstrual period), or surgically sterile, i.e. women of child bearing potential are not allowed to be included into the study. In cases of doubt a pregnancy test should be performed. (NB -post menopausal women currently receiving hormone replacement are permissible)
- Acute myocardial infarction < 12 h defined as:
- Subjects not able to give informed consent
- Left Bundle Branch Block
Inclusion and exclusion criteria
Inclusion criteria:
- Women must be postmenopausal (i.e.12 months without menstrual period), or surgically sterile, i.e. women of child bearing potential are not allowed to be included into the study. In cases of doubt a pregnancy test should be performed. (NB -post menopausal women currently receiving hormone replacement are permissible)
- Acute myocardial infarction < 12 h defined as: a. Angina or equivalent symptoms > 20 min and b. ST elevation in 2 contiguous ECG leads (= 2 mm precordial lead, = 1 mm limb lead). This ECG recording serves as baseline ECG, i.e. ECG I.
- Planned primary percutaneous coronary intervention
- The subject has given written informed, dated consent to participate in the study
Exclusion criteria:
- Subjects not able to give informed consent
- Left Bundle Branch Block
- Thrombolytic therapy within 24 hours before randomization
- Oral anticoagulation with International Normalized Ratio (INR) > 2
- Known platelets < 100.000/µl or known hemorrhagic diathesis
- Stroke or Transient Ischemic Attack (TIA) within the past 6 months or any permanent residual neurological defect
- Evidence of an active gastrointestinal or urogenital bleeding
- Major surgery within 6 weeks
- History of allergic reaction to abciximab or eptifibatide or any component used in the study (including contrast media)
- Known severe renal (creatinine clearance <30ml/min) or hepatic insufficiency as well as Alanine transaminase (ALT)/aspartate transaminase (AST) elevations = 3xUpper limit normal (ULN); isolated AST-elevation is not considered an exclusion criteria from study participation
- Severe concomitant disease with life expectation < 1 year
- Subject has participated in any study using an investigational drug or device within 30 days or within 5 half-lives of the investigational drug (whichever is longer) of entry into this study.
- Subjects who will be inaccessible due to geographic or social factors during treatment or follow-up
- In France, a subject is neither affiliated with nor a beneficiary of a social security category.
Trial location(s)
Location
GSK Investigational Site
Dortmund, Nordrhein-Westfalen, Germany, 44137
Status
Study Complete
Location
GSK Investigational Site
Neuss, Nordrhein-Westfalen, Germany, 41464
Status
Study Complete
Location
GSK Investigational Site
Ludwigshafen, Rheinland-Pfalz, Germany, 67063
Status
Study Complete
Location
GSK Investigational Site
Aachen, Nordrhein-Westfalen, Germany, 52074
Status
Study Complete
Location
GSK Investigational Site
Heidelberg, Baden-Wuerttemberg, Germany, 69120
Status
Study Complete
Location
GSK Investigational Site
Freiburg, Baden-Wuerttemberg, Germany, 79106
Status
Study Complete
Location
GSK Investigational Site
Moenchengladbach, Nordrhein-Westfalen, Germany, 41063
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2007-17-12
Actual study completion date
2007-17-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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