We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

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.
ClinicalTrials.gov Identifier: NCT02181998
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 14, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Drug: Full dose tenecteplase Drug: Unfractioned heparin Drug: Enoxaparin Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1606 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : July 2000
Primary Completion Date : August 2002

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: tenecteplase + unfractioned heparin Drug: Full dose tenecteplase Drug: Unfractioned heparin
Experimental: tenecteplase + enoxaparin Drug: Full dose tenecteplase Drug: Enoxaparin


Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
More Information

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02181998     History of Changes
Other Study ID Numbers: 1123.11
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 14, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Calcium heparin
Heparin
Tenecteplase
Tissue Plasminogen Activator
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action