Full Dose Tenecteplase (TNK-tPA) Together With Heparin Sodium, Full Dose Tenecteplase With Enoxaparin, Half Dose Tenecteplase Together With Abciximab and Heparin Sodium in Patients With Acute Myocardial Infarction (AMI)

Myocardial Infarction Clinical Trial

— ASSENT 3  

Official title:

A Phase IIIb, Randomised, Open Label Trial With 3 Parallel Groups: Full Dose TNK-tPA Together With Heparin Sodium, Full Dose TNK-tPA Together With Enoxaparin, and Half Dose TNK-tPA Together With Abciximab and Heparin Sodium in Patients With Acute Myocardial Infarction: ASSENT 3 (Assessment of the Safety and Efficacy of New Thrombolytic Regimens)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02181985
• Other study ID #: 1123.10
• 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: Argentina: Ministry of HealthAustralia: National Health and Medical Research CouncilAustria: Agency for Health and Food SafetyBelgium: Federal Agency for Medicines and Health Products, FAMHPBrazil: Ministry of HealthCanada: Health CanadaDenmark: Danish Health and Medicines AuthorityFinland: Finnish Medicines AgencyFrance: Agence Nationale de Sécurité du Médicament et des produits de santéGermany: Federal Institute for Drugs and Medical DevicesGreece: National Organization of MedicinesIreland: Irish Medicines BoardItaly: The Italian Medicines AgencyLuxembourg: Ministère de la SantéMexico: Ministry of HealthNetherlands: Medicines Evaluation Board (MEB)Norway: Norwegian Medicines AgencyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsPortugal: INFARMED, National Authority of Medicines and Health Products, IPSouth Africa: Department of HealthSpain: Agencia Española de Medicamentos y Productos SanitariosSweden: Medical Products AgencySwitzerland: Federal Office of Public HealthUnited Arab Emirates: Drug Control Department - Medicines and Pharmacy Control - Ministry of HealthUnited States: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

The objective of ASSENT 3 was to evaluate the safety and efficacy of full dose tenecteplase with heparin sodium (group A), full dose tenecteplase combined with enoxaparin (group B) and half dose tenecteplase combined with abciximab and heparin sodium (group C).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5989
• Est. primary completion date: April 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Onset of symptoms of AMI within six hours prior to randomisation

• A twelve-lead electrocardiogram with one of the following: 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 left bundle-branch block

• Age = 18

• Informed consent received

Exclusion Criteria:

• Hypertension defined as blood pressure > 180/110 mm Hg (systolic BP >180 mm Hg and/or diastolic BP >110 mm Hg) on repeated measurements during current admission prior to randomization

• Use of abciximab (ReoPro ®) or other glycoprotein-IIb/IIIa antagonists within the preceding 7 days

• Major surgery, biopsy of a parenchymal organ, or significant trauma within 2 months

• Any minor head trauma and any other trauma occurring after 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

• Prolonged cardiopulmonary resuscitation (>10 minutes) in the previous two weeks

• Current oral anticoagulation

• Standard unfractionated heparin (heparin sodium) >5000 IU or a subcutaneous dose within 6 hours of randomization of a therapeutic dose of any low molecular weight heparin

• Known thrombocytopenia (prior platelet count below 100000 cells/µl (100 x10**9/l))

• Known renal insufficiency (prior S-creatinine >2.5 mg% (>220 µmol/l) for men and >2.0 mg% (>175 µmol/l)) for women

• Pregnancy or lactation, parturition within the previous 30 days. Women of childbearing potential must have a negative pregnancy test, or use a medically accepted method of birth control

• Treatment with an investigational drug under another study protocol in the past 7 days

• Previous enrollment in this study

• Known sensitivity to TNK-tPA, tPA, abciximab, heparin or low molecular weight heparin

• Any other condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated

• Inability to follow 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:
• Full dose TNK-tPA

• Half dose TNK-tPA

• Heparin

• Enoxaparin

• Abciximab

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite endpoint: 30-day mortality or in-hospital reinfarction or in-hospital refractory ischemia or in-hospital intracranial hemorrhage (ICH) or in-hospital major bleedings (other than ICH)		Up to 30 days after discharge from hospital	Yes
Primary	Composite endpoints: 30-day mortality or in-hospital reinfarction or in-hospital refractory ischemia		Up to 30 days after discharge from hospital	No

External Links

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