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Completed

NCT Number: 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)

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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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tenecteplase

Drug

alteplase

Drug

Streptokinase

Drug

Primary outcomes

  1. Changes from baseline in concentration of thrombin anti-thrombin complex (TAT)

    Time frame: Baseline, 2 hours after start of treatment

Secondary outcomes

  1. Changes from baseline in TAT

    Time frame: Baseline, 6 and 24 hours after start of treatment

  2. Changes from baseline in D-dimers

    Time frame: Baseline, 2, 6 and 24 hours after start of treatment

  3. Changes from baseline in prothrombin fragments 1+2 (F1+F2)

    Time frame: Baseline, 2, 6 and 24 hours after start of treatment

  4. Changes from baseline in plasminogen-activator inhibitor-1 (PAI-1)

    Time frame: Baseline, 2, 6 and 24 hours after start of treatment

  5. Changes from baseline in plasmin-antiplasmin complex (PAP)

    Time frame: Baseline, 2, 6 and 24 hours after start of treatment

  6. Occurrence of adverse events (AE's)

    Time frame: Up to 30 days

  7. Occurrence of major bleedings

    Time frame: Up to 30 days

  8. Occurrence of minor bleedings

    Time frame: Up to 30 days

  9. Occurrence of serious adverse events (SAE's)

    Time frame: Up to 30 days

  10. Occurrence of in-hospital complications

    Time frame: Start of treatment until discharge from hospital

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
2000
Primary completion
2001
First posted
Jul 8, 2014
Registry last updated
Jul 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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