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Aspirin Reload Before Percutaneous Coronary Intervention: Reperfusion Indexes Evaluation.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01374698
Recruitment Status : Completed
First Posted : June 16, 2011
Last Update Posted : May 14, 2013
Information provided by (Responsible Party):
Francesco Violi, University of Roma La Sapienza

Brief Summary:
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 or disease Intervention/treatment Phase
Coronary Arteriosclerosis Drug: Aspirin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : January 2011
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
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

No Intervention: No intervention
No intervention

Primary Outcome Measures :
  1. 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 ]
    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 :
  1. Reperfusion Index [ Time Frame: At the end of the procedure (an expected average of 30 minutes) ]
    Changes of TFC and MBG (used to assess myocardial perfusion) before and after PCI.

  2. 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 ]
    At 60 and 120 minutes and at 6 hours after the procedure a blood sample collection will be performed to evaluate Myocardial necrosis indexes.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01374698

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Sapienza University of Rome
Rome, Italy, 00161
Sponsors and Collaborators
University of Roma La Sapienza
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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
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Francesco Violi, Prof., University of Roma La Sapienza Identifier: NCT01374698    
Other Study ID Numbers: Sapienza
First Posted: June 16, 2011    Key Record Dates
Last Update Posted: May 14, 2013
Last Verified: May 2013
Keywords provided by Francesco Violi, University of Roma La Sapienza:
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors