Clinical trial NCT01839890: Paclitaxel Eluting Balloon in St Elevation Myocardial Infarction
Official title: Study to Evaluate the Efficacy and Safety of Paclitaxel Eluting Balloon in St Elevation Myocardial Infarction After Bare Metal Stent Insertion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Myocardial Infarction
Keywords: Paclitaxel
stent
Acute infarction
Systolic time elevation
Lead sponsor: Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular
Sponsor class: OTHER
Collaborators: name: Effice Servicios Para la Investigacion S.L.
First posted: 2013-04-25
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Study objective is the evaluation of safety and efficacy at 9 months of combination treatment of bare metal Stent plus Paclitaxel Eluting Balloon vs bare metal stent (conventional treatment) in patients with acute myocardial infarction with systolic time elevation of less than 12 hours of evolution.

Detailed description: This is a multicenter, prospective, randomized, open study

After the permeabilization of the clinical event responsible artery and the insertion of a bare metal stent, patients will be randomized in a 1:1 ratio to one of the following treatment groups:

Group 1: post-dilatation with a paclitaxel eluting balloon (Pantera Lux ®) Group 2: no post-dilatation Patients (or their legal representative) must sign the consent before randomization.

After surgery, patients will be treated with dual antiplatelet therapy (aspirin plus clopidogrel) for at least one month to group 2 patients; and at least 3 months in those who are also treated with the paclitaxel eluting balloon (group 1). Aspirin is prescribed indefinitely according to the usual practice in these patients.

Patients will be monitored 30 days after surgery, at 6 and 12 months, and the ninth month (in which patient will receive an angiographic control).

The primary efficacy endpoint is late lumen loss (PLT) comparing it value during surgery and control angiography at 9 months

This study will involve patients over 18 years olds with systolic time elevation myocardial infarction, or new left bundle branch block or posterior AMI (ECG) that occur within 12 hours of onset of symptoms to treatment by primary angioplasty.

They include a total of 220 patients.

Eligibility criteria: Inclusion Criteria:

* Patients aged less than 18 years.
* Acute myocardial infarction (AMI) within 12 hours of evolution (from the onset of symptoms) systolic time elevation of at least 1 mm (recorded in two or more contiguous leads), new left bundle branch block, or true posterior infarction.
* Patients candidates for primary angioplasty as medical criteria
* Written informed consent according to International Conference on Harmonization / Guide Clinical Practice and local legislation, obtained before any study procedure.
* Diameter vascular coronary artery to treat between 2 mm and 4 mm.
* Patients with 90-100% stenosis.

Exclusion Criteria:

* Patients who refuse to participate in the study
* Cardiogenic shock (defined as systolic blood pressure less than 80 mm Hg for more than 30 minutes or need for vasopressors or intra-aortic balloon counterpulsation)
* Concomitant diseases associated with a life expectancy of less than one year
* Angiographic variables:

  * Trunk unprotected
  * Branching (side branch greater than 2.5 mm)
  * Sinus tachycardia segment elevation myocardial infarction thrombosis secondary to stent
  * If more than one stent to treat a single segment (overlapping stents).
  * Patient candidate for surgical revascularization within 30 days
  * Stenosis of greater than 30 mm in length (corresponding with the ball longer available)
  * Reference vessel diameter less than 2.5 mm and greater than 4 mm (larger ball)
  * More severe stenosis in the same artery in which is expected to be addressed in the next 9 months
* Women at childbearing age, where there is the possibility of pregnancy during the first year of follow-up, or nursing.
* Any clinical condition, which in the opinion of the investigator, is considered clinically significant as to participate in the study.
* Subjects who are participating in any study drug or medical.
* Individuals who show inability to follow instructions or help during the course of the study.
* Bleeding diathesis or other disorders such as gastrointestinal ulceration or cerebral circulatory disorders, restricting the use of treatments platelet aggregation inhibitors and anticoagulants.
* Patients with an ejection fraction \<30% (if known).
* Allergy or hypersensitivity to paclitaxel intolerance, or compounds structurally related to the Butyryl tri-n-hexyl citrate (BTHC) matrix of administration.
* Severe allergy to contrast media.
* Coronary artery spasm in the absence of significant stenosis.
* Cases in which is indicated bypass surgery within 30 days after infarction.

Primary outcomes:
measure: Late Luminal Loss
timeFrame: 1 year
Secondary outcomes:
measure: Efficacy
timeFrame: 1 year
measure: Safety
timeFrame: 1 year
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
facility: Complexo Hospitalario de Santiago
state: A Coruña
city: Puerto Real
country: Spain
facility: Hospital Universitario Puerto Real
state: Cádiz
city: Palma de Mallorca
country: Spain
facility: Hospital Son Espases
state: Islas Baleares
city: Majadahonda
country: Spain
facility: Hospital Puerta de Hierro
state: Madrid
city: El Palmar
country: Spain
facility: Hospital Virgen de la Arrixaca
state: Murcia
city: Pamplona
country: Spain
facility: Hospital de Navarra
state: Navarra
city: Galdakao
country: Spain
facility: Hospital Galdakao-Usanso
state: Vizcaya
city: Albacete
country: Spain
facility: Hospital General Universitario de Albacete
city: Badajoz
country: Spain
facility: H. Regional Universitario Infanta Cristina
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Universitario Valle de Hebrón
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial
city: Cáceres
country: Spain
facility: Hospital San Pedro de Alcantara
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Lleida
country: Spain
facility: Hospital Arnau de Vilanova
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Málaga
country: Spain
facility: Hospital Clínico Universitario Virgen de la Victoria
city: Málaga
country: Spain
facility: Hospital Regional Universitario Carlos Haya
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
Study officials:
affiliation: Hospital Universitario Puerta de Hierro. Majadahonda. Madrid
name: Francisco J. Goicolea, PhD
role: STUDY_DIRECTOR
References: