NCT02182011

Brief Summary

Primary objective: to evaluate the procoagulant effect of TNK-tPA compared to rt-PA and streptokinase, administered to patients with AMI, by measuring the concentration of TAT at 2 hours after the start of treatment versus baseline values. Secondary objective: change from baseline in concentration of TAT at 6 and 24 hours; change from baseline in concentration of D-dimers, F1+2, PAI-1, PAP at 2, 6 and 24 hours. Incidence of adverse events (AE's), in -hospital complications, major or minor bleedings and serious adverse events.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at below P25 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

May 1, 2000

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2001

Completed
13.1 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

1.1 years

First QC Date

July 2, 2014

Last Update Submit

July 11, 2014

Conditions

Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • Changes from baseline in concentration of thrombin anti-thrombin complex (TAT)

    Baseline, 2 hours after start of treatment

Secondary Outcomes (10)

  • Changes from baseline in TAT

    Baseline, 6 and 24 hours after start of treatment

  • Changes from baseline in D-dimers

    Baseline, 2, 6 and 24 hours after start of treatment

  • Changes from baseline in prothrombin fragments 1+2 (F1+F2)

    Baseline, 2, 6 and 24 hours after start of treatment

  • Changes from baseline in plasminogen-activator inhibitor-1 (PAI-1)

    Baseline, 2, 6 and 24 hours after start of treatment

  • Changes from baseline in plasmin-antiplasmin complex (PAP)

    Baseline, 2, 6 and 24 hours after start of treatment

  • +5 more secondary outcomes

Study Arms (3)

Tenecteplase

EXPERIMENTAL

Single i.v. bolus followed by infusion, weight adjusted

Drug: Tenecteplase

Alteplase

ACTIVE COMPARATOR

Single i.v. bolus followed by infusion

Drug: Alteplase

Streptokinase

ACTIVE COMPARATOR

I.V. infusion

Drug: Streptokinase

Interventions

TenecteplaseDRUG
Tenecteplase
AlteplaseDRUG
Alteplase
StreptokinaseDRUG
Streptokinase

Eligibility Criteria

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

You may qualify if:

  • Onset of symptoms of AMI within 6 hours from randomisation
  • A twelve-lead electrocardiogram (ECG) showing 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 new left bundle-branch block
  • Age ≥ 18

You may not qualify if:

  • Hypertension defined as blood pressure \> 180/110 mmHg (systolic BP \> 180 mmHg and/or diastolic BP \> 110 mmHg) on repeated measurements during current admission prior to randomisation
  • Use of abciximab (ReoPro®) within the preceding 7 days or eptifibatide (Integrilin®) or tirofiban (aggrastat®) within the past 48 hours
  • Use of heparin within the preceding 12 hours
  • Current therapeutic oral anticoagulation
  • Major surgery, biopsy of a parenchymal organ, or significant trauma within 2 months
  • Any minor head trauma and any other trauma occurring after the 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
  • Ruptured aortic aneurism
  • Active bleeding
  • Prolonged cardiopulmonary resuscitation (\> 10 minutes) in the previous two weeks
  • Pregnancy or lactation, parturition within the previous 30 days. Women of childbearing potential must have a negative pregnancy test
  • Any known active participation in another investigative drug study or device protocol in the past 30 days
  • Previous enrolment in this study
  • Any other condition that the investigator feels would place the patient at increased risk if the investigational therapy were initiated
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Myocardial Infarction

Interventions

TenecteplaseTissue Plasminogen ActivatorStreptokinase

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Serine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine ProteasesPlasminogen ActivatorsBlood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsBiological Factors

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

May 1, 2000

Primary Completion

June 1, 2001

Last Updated

July 14, 2014

Record last verified: 2014-07