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)

NCT02181985 | Completed Phase 3

• 1 other identifier: 1123.10
• Study Type: interventional
• Target: 5,989
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• Composite endpoint: 30-day mortality or in-hospital reinfarction or in-hospital refractory ischemia or in-hospital intracranial hemorrhage (ICH) or in-hospital major bleedings (other than ICH)

  Up to 30 days after discharge from hospital

• Composite endpoints: 30-day mortality or in-hospital reinfarction or in-hospital refractory ischemia

  Up to 30 days after discharge from hospital

Study Arms (3)

TNK-tPA + heparin

ACTIVE COMPARATOR

Drug: Full dose TNK-tPA; Drug: Heparin

TNK-tPA + enoxaparin

EXPERIMENTAL

Drug: Full dose TNK-tPA; Drug: Enoxaparin

TNK-tPA + abciximab + heparin

EXPERIMENTAL

Drug: Half dose TNK-tPA; Drug: Heparin; Drug: Abciximab

Interventions

Full dose TNK-tPA DRUG

TNK-tPA + enoxaparin; TNK-tPA + heparin

Half dose TNK-tPA DRUG

TNK-tPA + abciximab + heparin

Heparin DRUG

TNK-tPA + abciximab + heparin; TNK-tPA + heparin

Enoxaparin DRUG

TNK-tPA + enoxaparin

Abciximab DRUG

TNK-tPA + abciximab + heparin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Heparin; Enoxaparin; Abciximab

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Heparin, Low-Molecular-Weight; Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 8, 2014
• Study Start: May 1, 2000
• Primary Completion: April 1, 2001
• Last Updated: July 14, 2014

Record last verified: 2014-07