A Trial Evaluating the Efficacy and Safety of Tenecteplase Together With Unfractionated Heparin Prior to Early Percutaneous Coronary Intervention (PCI) as Compared to Standard Primary PCI in Patients With Acute Myocardial Infarction (ASSENT 4 PCI)

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00168792
• Date of registration: 09/09/2005
• Primary sponsor: Boehringer Ingelheim Pharmaceuticals
• Public title: A Trial Evaluating the Efficacy and Safety of Tenecteplase Together With Unfractionated Heparin Prior to Early Percutaneous Coronary Intervention (PCI) as Compared to Standard Primary PCI in Patients With Acute Myocardial Infarction (ASSENT 4 PCI)
• Scientific title: A Phase IIIb - IV, Randomised, Open Label Trial Evaluating the Efficacy and Safety of Tenecteplase Together With Unfractionated Heparin Prior to Early PCI as Compared to Standard Primary PCI in Patients With Acute Myocardial Infarction.
• Date of first enrolment: November 2003
• Target sample size: 4000
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00168792
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Austria, Belgium, Brazil, Canada, Czech Republic, France, Germany, Greece, Hungary, Ireland, Italy, Mexico, Norway, Poland, Portugal, Spain, Taiwan, Thailand, Turkey, United States

Contacts

• Name: Boehringer Ingelheim Study Coordinator
• Affiliation: Boehringer Ingelheim Pharmaceuticals

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients giving informed consent

- Patients with a large acute myocardial infarction randomised within 6 hours of
symptom onset

- Patients scheduled to undergo primary PCI

- Patients reaching the cath lab not before 60 min and not later than 3 hours after
randomisation

(Otherwise the patients fulfill the usual selection criteria for thrombolytic treatment
and PCI)

Exclusion Criteria: None



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Myocardial Infarction

Intervention(s)

Drug: Tenecteplase

Procedure: PCI

Primary Outcome(s)

As the main criteria for measuring clinical outcome, the frequency of death, heart failure or cardiogenic shock is compared in the two treatment groups during 90 days after the acute heart attack.

Secondary Outcome(s)

As a secondary outcome any other in-hospital complication and bleeds (including intracranial bleeds) are recorded and the frequency compared in the two treatment groups.

Furthermore, intracoronary blood flow measured during catheterisation before and after the PCI and a laboratory blood test (BNP) predicting developing heart failure are compared between the groups.

Secondary ID(s)

1123.12

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Genentech