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Abciximab

Phase 3

Infarction, Myocardial | Small molecule | Cardiovascular |GSK plc|Last Updated: Nov 27, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment429

FDA Designations

No designations recorded

Clinical trial landscape

Abciximab · 1 trial · 1 indication

Phase 3 1
NCT00426751Efficacy Of Eptifibatide Compared To Abciximab In Primary Percutaneous Coronary Intervention (PCI) For Acute ST Elevation Myocardial Infarction (STEMI)Infarction, Myocardial
COMPLETED429 Analytics
PHASE3COMPLETED
Efficacy Of Eptifibatide Compared To Abciximab In Primary Percutaneous Coronary Intervention (PCI) For Acute ST Elevation Myocardial Infarction (STEMI)
Infarction, MyocardialUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Complete Sum ST Resolution (STR) 60 Minutes (Min) After Percutaneous Coronary Intervention (PCI) (Per Protocol Population)
Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)

Sum STR was calculated as the difference between baseline (ECG I) and ECG III. The sum STR is the segment elevation resolution from all ECG leads associated with the infarct location. ST resolution, a method used to evaluate myocardial reperfusion, was expressed as a percentage of the baseline value (Complete: ≥ 70% resolution).

Number of Participants With Complete Sum ST Resolution (STR) 60 Min After Percutaneous Coronary Intervention (PCI) (Intent-to-Treat Population)
Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)

Sum STR was calculated as the difference between baseline (ECG I) and ECG III. The sum STR is the segment elevation resolution from all ECG leads associated with the infarct location. ST resolution, a method used to evaluate myocardial reperfusion, was expressed as a percentage of the baseline value (Complete: ≥ 70% resolution).

Secondary Endpoints

Number of Participants With Complete or Partial Sum ST Resolution (STR) 60 Min After PCI
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
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
Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AbciximabACTIVE_COMPARATORIntravenous bolus of 0.25 mg/kg followed by continuous intravenous infusion of 0.125 mcg/kg/min (max. 10 mcg/min) for 12 h after PCI.
EptifibatideEXPERIMENTALIntravenous bolus of 180 mcg/kg followed immediately by a continuous infusion of 2.0 mcg/kg/ min for 20-24 h after end of PCI, and a second bolus of 180 mcg/kg administered 10 min after the first bolus.

Interventions

NameTypeDescription
AbciximabDRUGIntravenous bolus of 0.25 mg/kg followed by continuous intravenous infusion of 0.125 mcg/kg/min (max. 10 mcg/min) for 12 h after PCI.
EptifibatideDRUGIntravenous bolus of 180 mcg/kg followed immediately by a continuous infusion of 2.0 mdg/kg/ min for 20-24 h after end of PCI, and a second bolus of 180 mcg/kg administered 10 min after the first bolus.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites24

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 recei...

Countries:FranceGermany
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Frequently asked questions about Abciximab

What is Abciximab used for?

Abciximab is used for myocardial infarction, specifically in the setting of primary percutaneous coronary intervention (PCI) for acute ST elevation myocardial infarction (STEMI). It is an investigational small molecule being studied in the cardiovascular therapeutic area.

Who makes Abciximab?

Abciximab is being developed by GSK plc, which trades under the ticker GSK. The company is conducting clinical research on this drug for the treatment of myocardial infarction.

What phase is Abciximab in?

Abciximab is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 trial has been completed for this asset.

What clinical trials is Abciximab in?

Abciximab has one completed Phase 3 trial, NCT00426751, titled 'Efficacy Of Eptifibatide Compared To Abciximab In Primary Percutaneous Coronary Intervention (PCI) For Acute ST Elevation Myocardial Infarction (STEMI)'. The trial enrolled 429 participants and was conducted in France and Germany.

Is Abciximab the same as Eptifibatide?

No, Abciximab is not the same as eptifibatide. In the clinical trial NCT00426751, eptifibatide was used as an active comparator against abciximab to evaluate their relative efficacy in primary PCI for acute STEMI.