Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2026-03-26 @ 3:04 AM
Study NCT ID:
NCT00168792
Status:
TERMINATED
Last Update Posted:
2013-10-29
First Post:
2005-09-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief 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)
Sponsor:
Organization:
Raw JSON
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Primary versus tenecteplase-facilitated percutaneous coronary intervention in patients with ST-segment elevation acute myocardial infarction (ASSENT-4 PCI): randomised trial. Lancet. 2006 Feb 18;367(9510):569-78. doi: 10.1016/S0140-6736(06)68147-6.'}, {'pmid': '21545942', 'type': 'DERIVED', 'citation': 'Zalewski J, Bogaerts K, Desmet W, Sinnaeve P, Berger P, Grines C, Danays T, Armstrong P, Van de Werf F. Intraluminal thrombus in facilitated versus primary percutaneous coronary intervention: an angiographic substudy of the ASSENT-4 PCI (Assessment of the Safety and Efficacy of a New Treatment Strategy with Percutaneous Coronary Intervention) trial. J Am Coll Cardiol. 2011 May 10;57(19):1867-73. doi: 10.1016/j.jacc.2010.10.061.'}, {'pmid': '20562693', 'type': 'DERIVED', 'citation': 'Jarai R, Huber K, Bogaerts K, Sinnaeve PR, Ezekowitz J, Ross AM, Zeymer U, Armstrong PW, Van de Werf FJ; ASSENT-4 PCI investigators. Prediction of cardiogenic shock using plasma B-type natriuretic peptide and the N-terminal fragment of its pro-hormone [corrected] concentrations in ST elevation myocardial infarction: an analysis from the ASSENT-4 Percutaneous Coronary Intervention Trial. Crit Care Med. 2010 Sep;38(9):1793-801. doi: 10.1097/CCM.0b013e3181eaaf2a.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients giving informed consent\n* Patients with a large acute myocardial infarction randomised within 6 hours of symptom onset\n* Patients scheduled to undergo primary PCI\n* Patients reaching the cath lab not before 60 min and not later than 3 hours after randomisation\n\n(Otherwise the patients fulfill the usual selection criteria for thrombolytic treatment and PCI)\n\nExclusion Criteria: None'}, 'identificationModule': {'nctId': 'NCT00168792', 'briefTitle': '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)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': '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. 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