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)

NCT ID: NCT02181985

Last Updated: 2014-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 5989 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-05-31

Brief Summary

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).

Conditions

Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TNK-tPA + heparin

Group Type: ACTIVE_COMPARATOR

Full dose TNK-tPA

Intervention Type: DRUG

Heparin

Intervention Type: DRUG

TNK-tPA + enoxaparin

Group Type: EXPERIMENTAL

Full dose TNK-tPA

Intervention Type: DRUG

Enoxaparin

Intervention Type: DRUG

TNK-tPA + abciximab + heparin

Group Type: EXPERIMENTAL

Half dose TNK-tPA

Intervention Type: DRUG

Heparin

Intervention Type: DRUG

Abciximab

Intervention Type: DRUG

Interventions

Full dose TNK-tPA

Intervention Type: DRUG

Half dose TNK-tPA

Intervention Type: DRUG

Heparin

Intervention Type: DRUG

Enoxaparin

Intervention Type: DRUG

Abciximab

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1123.10

Identifier Type: -

Identifier Source: org_study_id