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Drug Eluting Stent (DES) in Primary Angioplasty (PASEO)

This study has been completed.
Sponsor:
Information provided by:
San Giuseppe Moscati Hospital
ClinicalTrials.gov Identifier:
NCT00759850
First received: September 24, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  Purpose

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).


Condition Intervention Phase
Acute Myocardial Infarction
 Device: Drug Eluting Stent (DES)
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PaclitAxel or Sirolimus-Eluting Stent vs Bare Metal Stent in Primary Angioplasty (PASEO) Randomized Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by San Giuseppe Moscati Hospital:

Primary Outcome Measures:
  • The primary end point was target lesion revascularization (TLR) at 1-year follow-up [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 270
Study Start Date: October 2003
Study Completion Date: December 2007
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Patient with ST elevation myocardial infarction randomly assigned to receive a Bare Metal Stent n=90)
 Device: Drug Eluting Stent (DES)
Open-label randomization was performed after initial angiography by the treating physician when eligibility criteria were met. All patients received in the CCU 70U/Kg i.v. bolus of UFH plus 1000U/h infusion (to maintain an ACT of at least 200 seconds), aspirin intravenously (500 mg) and clopidogrel (300 mg loading dose). All patients received upstream Gp IIb-IIIa inhibitors administration as a routine adjunctive therapy before primary PCI. Postinterventional antiplatelet therapy for all patients included in the three study group, consisted of aspirin (100 mg) indefinitely and clopidogrel (75 mg for six months). Stenting procedures were performed according to standard techniques. The number and length of stents, and the type of BMS to be implanted, were left to the operator's discretion. The operator was allowed to implant DES to cover the entire length of the lesion with coverage of the entire stented segment and of 5 mm proximal and distal segments.
Other Names:
  • Primary Angioplasty
  • Cypher
  • Taxus
Experimental: B
Patient with ST elevation myocardial infarction randomly assigned to receive a Paclitaxel Eluting Stent (n=90)
 Device: Drug Eluting Stent (DES)
Open-label randomization was performed after initial angiography by the treating physician when eligibility criteria were met. All patients received in the CCU 70U/Kg i.v. bolus of UFH plus 1000U/h infusion (to maintain an ACT of at least 200 seconds), aspirin intravenously (500 mg) and clopidogrel (300 mg loading dose). All patients received upstream Gp IIb-IIIa inhibitors administration as a routine adjunctive therapy before primary PCI. Postinterventional antiplatelet therapy for all patients included in the three study group, consisted of aspirin (100 mg) indefinitely and clopidogrel (75 mg for six months). Stenting procedures were performed according to standard techniques. The number and length of stents, and the type of BMS to be implanted, were left to the operator's discretion. The operator was allowed to implant DES to cover the entire length of the lesion with coverage of the entire stented segment and of 5 mm proximal and distal segments.
Other Names:
  • Primary Angioplasty
  • Cypher
  • Taxus
Experimental: C
Patient with ST elevation myocardial infarction randomly assigned to receive a Sirolimus Eluting Stent (n=90)
 Device: Drug Eluting Stent (DES)
Open-label randomization was performed after initial angiography by the treating physician when eligibility criteria were met. All patients received in the CCU 70U/Kg i.v. bolus of UFH plus 1000U/h infusion (to maintain an ACT of at least 200 seconds), aspirin intravenously (500 mg) and clopidogrel (300 mg loading dose). All patients received upstream Gp IIb-IIIa inhibitors administration as a routine adjunctive therapy before primary PCI. Postinterventional antiplatelet therapy for all patients included in the three study group, consisted of aspirin (100 mg) indefinitely and clopidogrel (75 mg for six months). Stenting procedures were performed according to standard techniques. The number and length of stents, and the type of BMS to be implanted, were left to the operator's discretion. The operator was allowed to implant DES to cover the entire length of the lesion with coverage of the entire stented segment and of 5 mm proximal and distal segments.
Other Names:
  • Primary Angioplasty
  • Cypher
  • Taxus

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00759850

Locations
Italy
U.O. Cardiologia/UTIC
Avellino, Italy, 83100
Sponsors and Collaborators
San Giuseppe Moscati Hospital
Investigators
Principal Investigator: Emilio Di Lorenzo, MD PhD Division of Cardiology A.O. Moscati Avellino Italy
  More Information

No publications provided by San Giuseppe Moscati Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Emilio Di Lorenzo MD PhD, Division Of Cardiology
ClinicalTrials.gov Identifier: NCT00759850     History of Changes
Other Study ID Numbers: AOM_DES01
Study First Received: September 24, 2008
Last Updated: September 24, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by San Giuseppe Moscati Hospital:
Acute Myocardial Infarction
Drug Eluting Stent
Primary PCI

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013