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)

NCT02182011 — Phase 3, Completed, 49 participants, Boehringer Ingelheim

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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

Registry	NCT02182011
Status	Completed
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	49 (Actual)
Sponsor	Boehringer Ingelheim (Industry)
Conditions	Myocardial Infarction
Interventions	Tenecteplase, Alteplase, Streptokinase (Drug)
Dates	start 2000-05-01, primary completion 2001-06-01, first posted 2014-07-08, last updated 2014-07-14

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Tenecteplase	Experimental	Drug: Tenecteplase	Single i.v. bolus followed by infusion, weight adjusted
Alteplase	Active comparator	Drug: Alteplase	Single i.v. bolus followed by infusion
Streptokinase	Active comparator	Drug: Streptokinase	I.V. infusion

Tenecteplase (Drug)
Alteplase (Drug)
Streptokinase (Drug)

+Outcome measures

Primary outcomes

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

Secondary outcomes

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

Sex: All, ages: 18 Years to any

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

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