A Trial on Efficacy and Safety of Full Dose Tenecteplase Combined With Unfractionated Heparin (UFH) or Enoxaparin in Acute Myocardial Infarction (AMI) in the Prehospital Setting (ASSENT 3 Plus)

A Phase IIIb-IV, Randomised, Open Label Trial on Efficacy and Safety of 2 Parallel Groups: Full Dose Tenecteplase Combined With Unfractionated Heparin or Enoxaparin in Acute Myocardial Infarction in the Prehospital Setting (ASSENT 3 Plus) ASSENT 3 Plus Was a Satellite Study to ASSENT 3 (Main Study) ASSENT (ASsessment of the Safety and Efficacy of New Thrombolytic Regimens)

The primary objective of ASSENT 3 Plus (the same as for ASSENT 3) was to evaluate the safety and efficacy of full dose tenecteplase combined with unfractionated heparin (UFH, group A) and full dose tenecteplase combined with enoxaparin (ENOX, group B). An additional objective in ASSENT 3 Plus was to describe the different time intervals in the prehospital phase.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction
• Intervention / Treatment: Drug: Enoxaparin; Drug: Full dose tenecteplase; Drug: Unfractioned heparin

• Study Type: Interventional
• Enrollment (Actual): 1606
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Onset of symptoms of AMI within six hours prior to randomisation
• A 12-lead ECG 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 (BP) > 180/110 mmHg (systolic blood pressure (SBP) 180 mmHg and/or diastolic blood pressure (DBP) > 110 mmHg) on repeated measurements during current admission prior to randomisation
• Use of abciximab (ReoPro ®) or other glycoprotein-IIb/IIIa antagonists within the preceding seven days
• Major surgery, biopsy of a parenchymal organ, or significant trauma within two months
• Any minor head trauma and any other trauma occurring after onset of the current myocardial infarction (MI)
• Any known history of stroke or transient ischaemic attack or dementia
• Any known structural damage of the central nervous system
• Prolonged cardiopulmonary resuscitation (> 10 min) in the previous two weeks
• Current oral anticoagulation
• Standard UFH (heparin sodium) > 5000 international units (IU), or a subcutaneous (SC) therapeutic dose of any low molecular weight heparin (LMWH) within six hours of randomisation
• Known thrombocytopenia (prior platelet count below 100 000 cells/μL (100 x 10**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 had to 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 seven days
• Previous enrolment in this study
• Known sensitivity to tenecteplase, tissue plasminogen activator (tPA), abciximab, heparin or LMWH
• Any other condition that the investigator felt would place the patient at increased risk if the investigational therapy was initiated (e.g. known haemorrhagic diathesis, acute pericarditis and/or subacute bacterial endocarditis, acute pancreatitis, severe hepatic dysfunction, diabetic haemorrhagic retinopathy or other haemorrhagic ophthalmic conditions, active peptic ulceration, arterial aneurysm and known arterial/venous malformation, neoplasm with increased bleeding risk)
• Inability to follow protocol and comply with follow-up requirements

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: tenecteplase + unfractioned heparin	Drug: Full dose tenecteplase; Drug: Unfractioned heparin
Experimental: tenecteplase + enoxaparin	Drug: Enoxaparin; Drug: Full dose tenecteplase

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: July 1, 2000
• Primary Completion (Actual): August 1, 2002

Study Registration Dates

• First Submitted: July 2, 2014
• First Submitted That Met QC Criteria: July 2, 2014
• First Posted (Estimate): July 8, 2014

Study Record Updates

• Last Update Posted (Estimate): July 14, 2014
• Last Update Submitted That Met QC Criteria: July 11, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin; Enoxaparin; Tenecteplase
• Other Study ID Numbers: 1123.11