Full Dose Tenecteplase (TNK-tPA) Together With Heparin Sodium, Full Dose Tenecteplase With Enoxaparin, Half Dose Tenecteplase Together With Abciximab and Heparin Sodium in Patients With Acute Myocardial Infarction (AMI) (ASSENT 3)

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Myocardial Infarction

Treatments: Drug: Half dose TNK-tPA; Drug: Heparin; Drug: Abciximab; Drug: Enoxaparin; Drug: Full dose TNK-tPA

Study type: Interventional

Funder types: Industry

Identifiers

NCT02181985

1123.10

Details and patient eligibility

About

The objective of ASSENT 3 was to evaluate the safety and efficacy of full dose tenecteplase with heparin sodium (group A), full dose tenecteplase combined with enoxaparin (group B) and half dose tenecteplase combined with abciximab and heparin sodium (group C).

Enrollment: 5,989 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Onset of symptoms of AMI within six hours prior to randomisation
• A twelve-lead electrocardiogram with one of the following: ST-segment elevation ≥ 0.1 millivolt (mV) in two or more limb leads, or ≥ 0.2 mV in two or more contiguous precordial leads indicative of AMI, or left bundle-branch block
• Age ≥ 18
• Informed consent received

Exclusion criteria

• Hypertension defined as blood pressure > 180/110 mm Hg (systolic BP >180 mm Hg and/or diastolic BP >110 mm Hg) on repeated measurements during current admission prior to randomization
• Use of abciximab (ReoPro ®) or other glycoprotein-IIb/IIIa antagonists within the preceding 7 days
• Major surgery, biopsy of a parenchymal organ, or significant trauma within 2 months
• Any minor head trauma and any other trauma occurring after onset of the current myocardial infarction
• Any known history of stroke or transient ischemic attack or dementia
• Any known structural damage of the central nervous system
• Prolonged cardiopulmonary resuscitation (>10 minutes) in the previous two weeks
• Current oral anticoagulation
• Standard unfractionated heparin (heparin sodium) >5000 IU or a subcutaneous dose within 6 hours of randomization of a therapeutic dose of any low molecular weight heparin
• Known thrombocytopenia (prior platelet count below 100000 cells/μl (100 x10**9/l))
• Known renal insufficiency (prior S-creatinine >2.5 mg% (>220 μmol/l) for men and >2.0 mg% (>175 μmol/l)) for women
• Pregnancy or lactation, parturition within the previous 30 days. Women of childbearing potential must have a negative pregnancy test, or use a medically accepted method of birth control
• Treatment with an investigational drug under another study protocol in the past 7 days
• Previous enrollment in this study
• Known sensitivity to TNK-tPA, tPA, abciximab, heparin or low molecular weight heparin
• Any other condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated
• Inability to follow protocol and comply with follow-up requirements

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5,989 participants in 3 patient groups

TNK-tPA + heparin

Active Comparator group

Treatment:

Drug: Heparin

Drug: Full dose TNK-tPA

TNK-tPA + enoxaparin

Experimental group

Treatment:

Drug: Enoxaparin

Drug: Full dose TNK-tPA

TNK-tPA + abciximab + heparin

Experimental group

Treatment:

Drug: Abciximab

Drug: Heparin

Drug: Half dose TNK-tPA