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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02182011
First received: July 2, 2014
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Myocardial Infarction
Drug: Tenecteplase
Drug: Alteplase
Drug: Streptokinase
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Changes from baseline in concentration of thrombin anti-thrombin complex (TAT) [ Time Frame: Baseline, 2 hours after start of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes from baseline in TAT [ Time Frame: Baseline, 6 and 24 hours after start of treatment ] [ Designated as safety issue: No ]
  • Changes from baseline in D-dimers [ Time Frame: Baseline, 2, 6 and 24 hours after start of treatment ] [ Designated as safety issue: No ]
  • Changes from baseline in prothrombin fragments 1+2 (F1+F2) [ Time Frame: Baseline, 2, 6 and 24 hours after start of treatment ] [ Designated as safety issue: No ]
  • Changes from baseline in plasminogen-activator inhibitor-1 (PAI-1) [ Time Frame: Baseline, 2, 6 and 24 hours after start of treatment ] [ Designated as safety issue: No ]
  • Changes from baseline in plasmin-antiplasmin complex (PAP) [ Time Frame: Baseline, 2, 6 and 24 hours after start of treatment ] [ Designated as safety issue: No ]
  • Occurrence of adverse events (AE's) [ Time Frame: Up to 30 days ] [ Designated as safety issue: No ]
  • Occurrence of major bleedings [ Time Frame: Up to 30 days ] [ Designated as safety issue: Yes ]
  • Occurrence of minor bleedings [ Time Frame: Up to 30 days ] [ Designated as safety issue: Yes ]
  • Occurrence of serious adverse events (SAE's) [ Time Frame: Up to 30 days ] [ Designated as safety issue: No ]
  • Occurrence of in-hospital complications [ Time Frame: Start of treatment until discharge from hospital ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: May 2000
Primary Completion Date: June 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02182011     History of Changes
Other Study ID Numbers: 1123.5
Study First Received: July 2, 2014
Last Updated: July 11, 2014
Health Authority: Italy: The Italian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Tissue Plasminogen Activator
Tenecteplase
Streptokinase
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on September 16, 2014