NCT02181998

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,606

participants targeted

Target at P75+ for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2000

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2002

Completed
11.9 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 8, 2014

Completed
Last Updated

July 14, 2014

Status Verified

July 1, 2014

Enrollment Period

2.1 years

First QC Date

July 2, 2014

Last Update Submit

July 11, 2014

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 (2)

tenecteplase + unfractioned heparin

ACTIVE COMPARATOR
Drug: Full dose tenecteplaseDrug: Unfractioned heparin

tenecteplase + enoxaparin

EXPERIMENTAL
Drug: Full dose tenecteplaseDrug: Enoxaparin

Interventions

Full dose tenecteplaseDRUG
tenecteplase + enoxaparintenecteplase + unfractioned heparin
Unfractioned heparinDRUG
tenecteplase + unfractioned heparin
EnoxaparinDRUG
tenecteplase + enoxaparin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Enoxaparin

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

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

July 1, 2000

Primary Completion

August 1, 2002

Last Updated

July 14, 2014

Record last verified: 2014-07