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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02181985
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 14, 2014
Information provided by (Responsible Party):
Boehringer Ingelheim

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 Type : Interventional  (Clinical Trial)
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 2000
Actual Primary Completion Date : April 2001

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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) [ Time Frame: Up to 30 days after discharge from hospital ]
  2. Composite endpoints: 30-day mortality or in-hospital reinfarction or in-hospital refractory ischemia [ Time Frame: Up to 30 days after discharge from hospital ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Responsible Party: Boehringer Ingelheim Identifier: NCT02181985     History of Changes
Other Study ID Numbers: 1123.10
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 14, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Calcium heparin
Tissue Plasminogen Activator
Antibodies, Monoclonal
Immunoglobulin Fab Fragments
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Immunologic Factors
Physiological Effects of Drugs