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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)

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ClinicalTrials.gov Identifier: NCT02182011
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 14, 2014
Information provided by (Responsible Party):
Boehringer Ingelheim

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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Drug: Tenecteplase Drug: Alteplase Drug: Streptokinase Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2000
Primary Completion Date : June 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Changes from baseline in concentration of thrombin anti-thrombin complex (TAT) [ Time Frame: Baseline, 2 hours after start of treatment ]

Secondary Outcome Measures :
  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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02182011     History of Changes
Other Study ID Numbers: 1123.5
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 14, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action