| September 24, 2008 |
| September 24, 2008 |
| October 2003 |
| October 2005 (final data collection date for primary outcome measure) |
| The primary end point was target lesion revascularization (TLR) at 1-year follow-up [ Time Frame: 1 year ] [ Designated as safety issue: No ] |
| Same as current |
| No Changes Posted |
| Cumulative combined incidence of death and/or reinfarction at 2 year; Cumulative incidence of in-stent thrombosis at 2 year; 3) Major Adverse Cardiac Events (MACE) (combined death and/or reinfarction and/or TLR) at 2 years [ Time Frame: 2 year ] [ Designated as safety issue: Yes ] |
| Same as current |
| |
| Drug Eluting Stent (DES) in Primary Angioplasty |
| PaclitAxel or Sirolimus-Eluting Stent vs Bare Metal Stent in Primary Angioplasty (PASEO) Randomized Trial |
Stent implantation is the best treatment in patients with acute myocardial infarction (STEMI) referred for primary angioplasty (pPCI). However the occurrence of in stent restenosis is responsible for the need of repeat intervention. Both Sirolimus-eluting stents (SES) and Paclitaxel-eluting stents (PES) have been proven to virtually abolish in-stent restenosis in elective patients in simple e more complex lesions. Both SES and PES have raised concerns regarding occurrence of late stent thrombosis, especially in complex lesion subsets or in high risk patients. The PaclitAxel or Sirolimus-Eluting Stent vs Bare Metal Stent in primary angioplasty (PASEO) trial was a prospective, single-center, randomized trial evaluating the benefits of SES or PES as compared to BMS implantation in patients undergoing primary angioplasty for acute STEMI. From 1 October 2003 we randomized with 1:1:1 ratio, 270 patients with STEMI and treated with pPCI, to implantation of a bare metal stent (BMS n=90), PES (n=90) or SES (n=90). |
| |
| Phase II, Phase III |
| Interventional |
| Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Acute Myocardial Infarction |
| Device: Drug Eluting Stent (DES) |
- Active Comparator: Patient with ST elevation myocardial infarction randomly assigned to receive a Bare Metal Stent n=90)
- Experimental: Patient with ST elevation myocardial infarction randomly assigned to receive a Paclitaxel Eluting Stent (n=90)
- Experimental: Patient with ST elevation myocardial infarction randomly assigned to receive a Sirolimus Eluting Stent (n=90)
|
- Di Lorenzo E, Sauro R, Varricchio A, Capasso M, Lanzillo T, Manganelli F, Mariello C, Siano F, Pagliuca MR, Stanco G, Rosato G, De Luca G. Benefits of drug-eluting stents as compared to bare metal stent in ST-segment elevation myocardial infarction: four year results of the PaclitAxel or Sirolimus-Eluting stent vs bare metal stent in primary angiOplasty (PASEO) randomized trial. Am Heart J. 2009 Oct;158(4):e43-50.
- Di Lorenzo E, De Luca G, Sauro R, Varricchio A, Capasso M, Lanzillo T, Manganelli F, Mariello C, Siano F, Pagliuca MR, Stanco G, Rosato G. The PASEO (PaclitAxel or Sirolimus-Eluting Stent Versus Bare Metal Stent in Primary Angioplasty) Randomized Trial. JACC Cardiovasc Interv. 2009 Jun;2(6):515-23.
|
| |
| Completed |
| 270 |
| December 2007 |
| October 2005 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Clinical symptoms of STEMI, with initial onset of chest pain within the past 12 hours, an ECG demonstrating > 0.1 mV ST-segment elevation in 2 or more contiguous leads or documented new left bundle-branch block and were suitable candidates for percutaneous revascularization.
Exclusion Criteria:
- Active internal bleeding or a history of bleeding diathesis within the previous 30 days
- An history of intracranial hemorrhage
- Intracranial neoplasm
- Arteriovenous malformation or aneurysm
- Known allergy to sirolimus
- Paclitaxel
- Heparin, aspirin, or clopidogrel
- An history of stroke within 30 days or any history of hemorrhagic stroke
- History, symptoms, or findings suggestive of aortic dissection, fibrinolytic therapy within 24 hours
- History of thrombocytopenia, pregnancy, patients on warfarin or acenocoumarol within the last seven days
- Inability to obtain the informed consent
|
| Both |
| 18 Years to 85 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Italy |
| |
| NCT00759850 |
| Emilio Di Lorenzo MD PhD, Division Of Cardiology |
| AOM_DES01 |
| San Giuseppe Moscati Hospital |
|
| Principal Investigator: |
Emilio Di Lorenzo, MD PhD |
Division of Cardiology A.O. Moscati Avellino Italy |
|
|
| San Giuseppe Moscati Hospital |
| September 2008 |