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Completed

NCT Number: NCT00759850

Drug Eluting Stent (DES) in Primary Angioplasty

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).

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Key information

Conditions

Acute Myocardial Infarction

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

U.O. Cardiologia/UTIC

Avellino, 83100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Drug Eluting Stent (DES)

Device

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

Primary outcomes

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

    Time frame: 1 year

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

San Giuseppe Moscati Hospital

Other

Registry information

Official study title

PaclitAxel or Sirolimus-Eluting Stent vs Bare Metal Stent in Primary Angioplasty (PASEO) Randomized Trial

Acronym: PASEO

Important dates

Study start
2003
Primary completion
2005
Study completion
2007
First posted
Sep 25, 2008
Registry last updated
Sep 25, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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