A Study to Investigate the Procoagulant Effect of Tenecteplase (TNK-tPA), Alteplase (Rt-PA) and Streptokinase (SK) Administered to Patients With Acute Myocardial Infarction (AMI)

Sponsor

Boehringer Ingelheim (Industry)

Overall Status

Completed

CT.gov ID

NCT02182011

Collaborator

(none)

Enrollment

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction	Drug: Tenecteplase Drug: Alteplase Drug: Streptokinase	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

49 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-label, Randomised, Parallel-group Comparison to Investigate the Procoagulant Effect of Tenecteplase (TNK-tPA), Alteplase (Rt-PA) and Streptokinase (SK) Administered to Patients With AMI

Study Start Date :

May 1, 2000

Actual Primary Completion Date :

Jun 1, 2001

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tenecteplase Single i.v. bolus followed by infusion, weight adjusted	Drug: Tenecteplase
Active Comparator: Alteplase Single i.v. bolus followed by infusion	Drug: Alteplase
Active Comparator: Streptokinase I.V. infusion	Drug: Streptokinase

Arm

Intervention/Treatment

Experimental: Tenecteplase

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

Drug: Tenecteplase

Active Comparator: Alteplase

Single i.v. bolus followed by infusion

Drug: Alteplase

Active Comparator: Streptokinase

I.V. infusion

Drug: Streptokinase

Outcome Measures

Primary Outcome Measures

Changes from baseline in concentration of thrombin anti-thrombin complex (TAT) [Baseline, 2 hours after start of treatment]

Secondary Outcome Measures

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]
Occurrence of adverse events (AE's) [Up to 30 days]
Occurrence of major bleedings [Up to 30 days]
Occurrence of minor bleedings [Up to 30 days]
Occurrence of serious adverse events (SAE's) [Up to 30 days]
Occurrence of in-hospital complications [Start of treatment until discharge from hospital]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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
Inability to follow the protocol and comply with follow-up requirements