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

Primary Purpose

Acute Myocardial Infarction

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Drug Eluting Stent (DES)
Sponsored by
San Giuseppe Moscati Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Acute Myocardial Infarction, Drug Eluting Stent, Primary PCI

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • U.O. Cardiologia/UTIC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

A

B

C

Arm Description

Patient with ST elevation myocardial infarction randomly assigned to receive a Bare Metal Stent n=90)

Patient with ST elevation myocardial infarction randomly assigned to receive a Paclitaxel Eluting Stent (n=90)

Patient with ST elevation myocardial infarction randomly assigned to receive a Sirolimus Eluting Stent (n=90)

Outcomes

Primary Outcome Measures

The primary end point was target lesion revascularization (TLR) at 1-year follow-up

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

Full Information

First Posted
September 24, 2008
Last Updated
September 24, 2008
Sponsor
San Giuseppe Moscati Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00759850
Brief Title
Drug Eluting Stent (DES) in Primary Angioplasty
Acronym
PASEO
Official Title
PaclitAxel or Sirolimus-Eluting Stent vs Bare Metal Stent in Primary Angioplasty (PASEO) Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
San Giuseppe Moscati Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
Acute Myocardial Infarction, Drug Eluting Stent, Primary PCI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
270 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Patient with ST elevation myocardial infarction randomly assigned to receive a Bare Metal Stent n=90)
Arm Title
B
Arm Type
Experimental
Arm Description
Patient with ST elevation myocardial infarction randomly assigned to receive a Paclitaxel Eluting Stent (n=90)
Arm Title
C
Arm Type
Experimental
Arm Description
Patient with ST elevation myocardial infarction randomly assigned to receive a Sirolimus Eluting Stent (n=90)
Intervention Type
Device
Intervention Name(s)
Drug Eluting Stent (DES)
Other Intervention Name(s)
Primary Angioplasty, Cypher, Taxus
Intervention Description
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.
Primary Outcome Measure Information:
Title
The primary end point was target lesion revascularization (TLR) at 1-year follow-up
Time Frame
1 year
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emilio Di Lorenzo, MD PhD
Organizational Affiliation
Division of Cardiology A.O. Moscati Avellino Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
U.O. Cardiologia/UTIC
City
Avellino
ZIP/Postal Code
83100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
19781402
Citation
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. doi: 10.1016/j.ahj.2009.03.016.
Results Reference
derived
PubMed Identifier
19539255
Citation
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. doi: 10.1016/j.jcin.2009.03.012.
Results Reference
derived

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Drug Eluting Stent (DES) in Primary Angioplasty

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