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)

Myocardial Infarction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02182011
• Other study ID #: 1123.5
• Status: Completed
• Phase: Phase 3
• First received: July 2, 2014
• Last updated: July 11, 2014
• Start date: May 2000

Study information

• Verified date: July 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines AgencyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. primary completion date: June 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Drug:
• Tenecteplase

• Alteplase

• Streptokinase

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline in concentration of thrombin anti-thrombin complex (TAT)		Baseline, 2 hours after start of treatment	No
Secondary	Changes from baseline in TAT		Baseline, 6 and 24 hours after start of treatment	No
Secondary	Changes from baseline in D-dimers		Baseline, 2, 6 and 24 hours after start of treatment	No
Secondary	Changes from baseline in prothrombin fragments 1+2 (F1+F2)		Baseline, 2, 6 and 24 hours after start of treatment	No
Secondary	Changes from baseline in plasminogen-activator inhibitor-1 (PAI-1)		Baseline, 2, 6 and 24 hours after start of treatment	No
Secondary	Changes from baseline in plasmin-antiplasmin complex (PAP)		Baseline, 2, 6 and 24 hours after start of treatment	No
Secondary	Occurrence of adverse events (AE's)		Up to 30 days	No
Secondary	Occurrence of major bleedings		Up to 30 days	Yes
Secondary	Occurrence of minor bleedings		Up to 30 days	Yes
Secondary	Occurrence of serious adverse events (SAE's)		Up to 30 days	No
Secondary	Occurrence of in-hospital complications		Start of treatment until discharge from hospital	No

External Links

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