Clinical trial NCT02182011: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myocardial Infarction
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-08
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Changes from baseline in concentration of thrombin anti-thrombin complex (TAT)
timeFrame: Baseline, 2 hours after start of treatment
Secondary outcomes:
measure: Changes from baseline in TAT
timeFrame: Baseline, 6 and 24 hours after start of treatment
measure: Changes from baseline in D-dimers
timeFrame: Baseline, 2, 6 and 24 hours after start of treatment
measure: Changes from baseline in prothrombin fragments 1+2 (F1+F2)
timeFrame: Baseline, 2, 6 and 24 hours after start of treatment
measure: Changes from baseline in plasminogen-activator inhibitor-1 (PAI-1)
timeFrame: Baseline, 2, 6 and 24 hours after start of treatment
measure: Changes from baseline in plasmin-antiplasmin complex (PAP)
timeFrame: Baseline, 2, 6 and 24 hours after start of treatment
measure: Occurrence of adverse events (AE's)
timeFrame: Up to 30 days
measure: Occurrence of major bleedings
timeFrame: Up to 30 days
measure: Occurrence of minor bleedings
timeFrame: Up to 30 days
measure: Occurrence of serious adverse events (SAE's)
timeFrame: Up to 30 days
measure: Occurrence of in-hospital complications
timeFrame: Start of treatment until discharge from hospital
Other outcomes:
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