Aspirin Reload Before Percutaneous Coronary Intervention: Reperfusion Indexes Evaluation.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Francesco Violi, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01374698
First received: May 6, 2011
Last updated: May 13, 2013
Last verified: May 2013
  Purpose

This is a prospective, randomized study conducted in patients undergoing coronary revascularization procedures (PCI) through angioplasty. All patients who meet the eligibility criteria will be randomized to receive, before the procedure, an oral aspirin reload (325 mg) and to be re-evaluated at 60 minutes, 120 minutes, 6 hours, 48 hours, 5 and 30 day, 3 and 6 months.


Condition Intervention Phase
Coronary Arteriosclerosis
Drug: Aspirin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Preprocedural Asprin Reload for Native Coronary Disease Treated by Angioplasty: Reperfusion Indexes Evaluation and Improvement of Clinical Outcome -PANTAREI Study

Resource links provided by NLM:


Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:
  • Evaluation of pre procedural aspirin overload effect on markers of platelet activation after percutaneous coronary intervention (PCI) [ Time Frame: Change from baseline at 120 minutes ] [ Designated as safety issue: Yes ]
    Changes from the baseline of platelet activation markers (thromboxane) after 60, 120 minutes and 6 hours from the end of percutaneous coronary intervention.


Secondary Outcome Measures:
  • Reperfusion Index [ Time Frame: At the end of the procedure (an expected average of 30 minutes) ] [ Designated as safety issue: Yes ]
    Changes of TFC and MBG (used to assess myocardial perfusion) before and after PCI.

  • Myocardial damage assessed by mean peak values of cardiac troponin I (cTnI) after the percutaneous coronary procedure. [ Time Frame: Changes from baseline at 6 hours ] [ Designated as safety issue: Yes ]
    At 60 and 120 minutes and at 6 hours after the procedure a blood sample collection will be performed to evaluate Myocardial necrosis indexes.


Enrollment: 100
Study Start Date: January 2011
Study Completion Date: September 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Aspirin
All patients who meet the eligibility criteria will be randomized in a 1:1 manner to receive, before the coronary percutaneous procedure, an oral aspirin reload (325 mg)or placebo.
Drug: Aspirin
Aspirin 325 mg
Other Name: Aspirin
No Intervention: No intervention
No intervention

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  • De novo native coronary chronic occlusion with a reference diameter equal or superior to 3 mm programmed treatment;
  • 100 mg/die oral aspirin treatment for at least 7 days before the procedure;
  • Target lesion must be covered with two stent maximum with a maximum length ≤ 33 mm each
  • Signed written informed consent

Exclusion Criteria:

  • Aspirin, bisulphate clopidogrel, ticlopidine, heparin, contrast agent or heavy metals known allergy that cannot been medically handled;
  • Target occlusion localized inside a previously implanted graft
  • Target occlusion localized inside a vessel segment previously underwent stent-positioning
  • Target occlusion localized inside a vessel with other occlusion not-to-be treated with the target occlusion same stent(s)
  • Target occlusion localized inside a vessel with other occlusions need to be treated with balloon angioplasty
  • Other techniques than balloon angioplasty target occlusion pre-treatment such as atherectomy, laser intervention or thrombectomy
  • Coronary brachytherapy treated patients
  • Ejection fraction equal or minor to 30%
  • Renal insufficiency (creatinine >3.0 mg/dl)
  • Warfarin-treated patients
  • Life expectancy minor to 12 months
  • Heart transplanted patients
  • Patients still enrolled in some other study, both pharmacological both not
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01374698

Locations
Italy
Sapienza University of Rome
Rome, Italy, 00161
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
Principal Investigator: Stefania Basili, MD Sapienza-Univerity of Rome
Study Chair: Violi Francesco, Prof. Sapienza
Principal Investigator: Gaetano Tanzilli, Prof. Sapienza
Principal Investigator: Marcello Dominici, MD Division of Cardiology, Department of Interventional Cardiology, Santa Maria University Hospital, Terni, Italy
  More Information

No publications provided

Responsible Party: Francesco Violi, Prof., University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT01374698     History of Changes
Other Study ID Numbers: Sapienza
Study First Received: May 6, 2011
Last Updated: May 13, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by University of Roma La Sapienza:
PCI
Aspirin
Reload

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 26, 2014