ASSENT 3: 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)

Sponsor

Boehringer Ingelheim (Industry)

Overall Status

Completed

CT.gov ID

NCT02181985

Collaborator

(none)

5,989

Enrollment

Arms

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction	Drug: Full dose TNK-tPA Drug: Half dose TNK-tPA Drug: Heparin Drug: Enoxaparin Drug: Abciximab	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

5989 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase IIIb, Randomised, Open Label Trial With 3 Parallel Groups: Full Dose TNK-tPA Together With Heparin Sodium, Full Dose TNK-tPA Together With Enoxaparin, and Half Dose TNK-tPA Together With Abciximab and Heparin Sodium in Patients With Acute Myocardial Infarction: ASSENT 3 (Assessment of the Safety and Efficacy of New Thrombolytic Regimens)

Study Start Date :

May 1, 2000

Actual Primary Completion Date :

Apr 1, 2001

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: TNK-tPA + heparin	Drug: Full dose TNK-tPA Drug: Heparin
Experimental: TNK-tPA + enoxaparin	Drug: Full dose TNK-tPA Drug: Enoxaparin
Experimental: TNK-tPA + abciximab + heparin	Drug: Half dose TNK-tPA Drug: Heparin Drug: Abciximab

Arm

Intervention/Treatment

Active Comparator: TNK-tPA + heparin

Drug: Full dose TNK-tPA

Drug: Heparin

Experimental: TNK-tPA + enoxaparin

Drug: Full dose TNK-tPA

Drug: Enoxaparin

Experimental: TNK-tPA + abciximab + heparin

Drug: Half dose TNK-tPA

Drug: Heparin

Drug: Abciximab

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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