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)

Boehringer Ingelheim logo

Boehringer Ingelheim

Status and phase

Terminated
Phase 4

Conditions

Myocardial Infarction

Treatments

Drug: Tenecteplase
Procedure: PCI

Study type

Interventional

Funder types

Industry

Identifiers

NCT00168792
1123.12

Details and patient eligibility

About

To show whether addition of thrombolytic treatment by a single bolus injection of tenecteplase prior to early standard PCI (percutaneous coronary intervention) will improve the clinical outcome in patients with large acute myocardial infarcts as compared to primary PCI alone.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

177

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Data sourced from clinicaltrials.gov

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