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)

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

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction
• Intervention / Treatment: Drug: Tenecteplase; Drug: Streptokinase; Drug: Alteplase

• Study Type: Interventional
• Enrollment (Actual): 49
• 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 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

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

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes from baseline in concentration of thrombin anti-thrombin complex (TAT)	Baseline, 2 hours after start of treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: May 1, 2000
• Primary Completion (Actual): June 1, 2001

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; Tissue Plasminogen Activator; Tenecteplase; Streptokinase
• Other Study ID Numbers: 1123.5