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)
Primary Purpose
Myocardial Infarction
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Tenecteplase
Alteplase
Streptokinase
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Tenecteplase
Alteplase
Streptokinase
Arm Description
Single i.v. bolus followed by infusion, weight adjusted
Single i.v. bolus followed by infusion
I.V. infusion
Outcomes
Primary Outcome Measures
Changes from baseline in concentration of thrombin anti-thrombin complex (TAT)
Secondary Outcome Measures
Changes from baseline in TAT
Changes from baseline in D-dimers
Changes from baseline in prothrombin fragments 1+2 (F1+F2)
Changes from baseline in plasminogen-activator inhibitor-1 (PAI-1)
Changes from baseline in plasmin-antiplasmin complex (PAP)
Occurrence of adverse events (AE's)
Occurrence of major bleedings
Occurrence of minor bleedings
Occurrence of serious adverse events (SAE's)
Occurrence of in-hospital complications
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02182011
Brief Title
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)
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 Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
May 2000 (undefined)
Primary Completion Date
June 2001 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tenecteplase
Arm Type
Experimental
Arm Description
Single i.v. bolus followed by infusion, weight adjusted
Arm Title
Alteplase
Arm Type
Active Comparator
Arm Description
Single i.v. bolus followed by infusion
Arm Title
Streptokinase
Arm Type
Active Comparator
Arm Description
I.V. infusion
Intervention Type
Drug
Intervention Name(s)
Tenecteplase
Intervention Type
Drug
Intervention Name(s)
Alteplase
Intervention Type
Drug
Intervention Name(s)
Streptokinase
Primary Outcome Measure Information:
Title
Changes from baseline in concentration of thrombin anti-thrombin complex (TAT)
Time Frame
Baseline, 2 hours after start of treatment
Secondary Outcome Measure Information:
Title
Changes from baseline in TAT
Time Frame
Baseline, 6 and 24 hours after start of treatment
Title
Changes from baseline in D-dimers
Time Frame
Baseline, 2, 6 and 24 hours after start of treatment
Title
Changes from baseline in prothrombin fragments 1+2 (F1+F2)
Time Frame
Baseline, 2, 6 and 24 hours after start of treatment
Title
Changes from baseline in plasminogen-activator inhibitor-1 (PAI-1)
Time Frame
Baseline, 2, 6 and 24 hours after start of treatment
Title
Changes from baseline in plasmin-antiplasmin complex (PAP)
Time Frame
Baseline, 2, 6 and 24 hours after start of treatment
Title
Occurrence of adverse events (AE's)
Time Frame
Up to 30 days
Title
Occurrence of major bleedings
Time Frame
Up to 30 days
Title
Occurrence of minor bleedings
Time Frame
Up to 30 days
Title
Occurrence of serious adverse events (SAE's)
Time Frame
Up to 30 days
Title
Occurrence of in-hospital complications
Time Frame
Start of treatment until discharge from hospital
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1123/1123.5_U02-1039.pdf
Description
Related Info
Learn more about this trial
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)
We'll reach out to this number within 24 hrs