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Aspirin Reload Before Percutaneous Coronary Intervention: Reperfusion Indexes Evaluation.

Primary Purpose

Coronary Arteriosclerosis

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Aspirin
Sponsored by
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Arteriosclerosis focused on measuring PCI, Aspirin, Reload

Eligibility Criteria

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

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

Sites / Locations

  • Sapienza University of Rome

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Aspirin

No intervention

Arm Description

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.

No intervention

Outcomes

Primary Outcome Measures

Evaluation of pre procedural aspirin overload effect on markers of platelet activation after percutaneous coronary intervention (PCI)
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
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.
At 60 and 120 minutes and at 6 hours after the procedure a blood sample collection will be performed to evaluate Myocardial necrosis indexes.

Full Information

First Posted
May 6, 2011
Last Updated
May 13, 2013
Sponsor
University of Roma La Sapienza
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1. Study Identification

Unique Protocol Identification Number
NCT01374698
Brief Title
Aspirin Reload Before Percutaneous Coronary Intervention: Reperfusion Indexes Evaluation.
Official Title
Preprocedural Asprin Reload for Native Coronary Disease Treated by Angioplasty: Reperfusion Indexes Evaluation and Improvement of Clinical Outcome -PANTAREI Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Study population will be composed of 60 patients with a native coronary chronic occlusion with a vessel diameter equal or superior to 3 mm. The vessels must be treated through a balloon angioplasty and must be completely covered with two stent maximum with a maximum length ≤ 33 mm each. The native coronary chronic occlusion is defined as a native coronary obstruction, if established from at least 30 days, without lumen continuity and a "Thrombolysis In Myocardial Infarction" (TIMI) flow grade equal or superior to 1. Patient must be treated with an chronic (at least 7 days) oral 100 mg/die aspirin treatment. After the eligibility criteria confirmation, the patient will be randomized with a 1:1 ratio to receive the aspirin reload or not. Coronary angiographies will be evaluated by the centralized laboratory with the Coronary Quantitative Angiography method. Myocardial necrosis indexes, ejection fraction, TIMI frame count (TFC) and myocardial blush grade (MBG) variations will represent the short term primary end-points. Clinical events incidence, including death, myocardial infarction, target vessel revascularization and stent thrombosis, will be evaluated at 1, 6 and 12 months. Study design In every patient will be performed a baseline blood sample collection to evaluate inflammation, platelet activation and oxidative stress indexes. After baseline collection of blood samples, computer-generated random sequence were used for randomization to an oral aspirin reload administration or not. Every patient, as guidelines described, will receive an oral clopidogrel reload (300 mg) that will be turned to 75 mg/die oral administration for the next 6 months. After procedure, the patient will turn back to the chronic aspirin 100 mg/die oral treatment. After a percutaneous access will be obtained, it will be administered a 5000 U unfractioned heparin bolus, treating the dose to obtain a clotting time equal or superior to 250 seconds during the intervention. A basal angiography will be performed in at least two orthogonal adjoining projections using a diagnostic 6F catheter. Every angiograms must include at least 2 cm catheter length to allow accurate quantitative coronary angiographic evaluations. Target lesion will be crossed by a 0,0014" metallic guide and a single proper-dimensions-balloon predilatation will be performed inflating a nominal pression to the balloon for 15 seconds long. In 1 minute from the dilatation will be implanted a sirolimus eluting stent (SES; Cypher ™, Cordis, Johnson& Johnson). Stent deployment will be obtained by an high pressure 10 seconds balloon inflate (more than 15 atm) without any second dilatation. No direct stent implantation will be realized. TFC and MBG will be evaluated before and after the procedure. At 60 and 120 minutes and at 6 hours after the procedure a blood sample collection will be performed to evaluate the same baseline indexes. After 48 hours, 5 and 30 day ejection fraction will be re-evaluated. Every 3 months, for 12 months at least, patient will receive an ambulatorial follow up to recognize the new ischemic symptoms or instrumental signs onset. Statistical Considerations Previous observations reported that after revascularization procedure has been observed a 35% plasmatic thromboxane levels increase (in vivo platelet activation index) in patients receiving chronic aspirin treatment (7 days). Hypothesizing that the oral aspirin reload could produce a 25% absolute reduction in plasmatic thromboxane levels (10%) this study needs a 50 patients for every treatment arm sample size (1-beta=90%; alfa=5%).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Arteriosclerosis
Keywords
PCI, Aspirin, Reload

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aspirin
Arm Type
Active Comparator
Arm Description
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.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
Aspirin 325 mg
Primary Outcome Measure Information:
Title
Evaluation of pre procedural aspirin overload effect on markers of platelet activation after percutaneous coronary intervention (PCI)
Description
Changes from the baseline of platelet activation markers (thromboxane) after 60, 120 minutes and 6 hours from the end of percutaneous coronary intervention.
Time Frame
Change from baseline at 120 minutes
Secondary Outcome Measure Information:
Title
Reperfusion Index
Description
Changes of TFC and MBG (used to assess myocardial perfusion) before and after PCI.
Time Frame
At the end of the procedure (an expected average of 30 minutes)
Title
Myocardial damage assessed by mean peak values of cardiac troponin I (cTnI) after the percutaneous coronary procedure.
Description
At 60 and 120 minutes and at 6 hours after the procedure a blood sample collection will be performed to evaluate Myocardial necrosis indexes.
Time Frame
Changes from baseline at 6 hours

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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefania Basili, MD
Organizational Affiliation
Sapienza-Univerity of Rome
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Violi Francesco, Prof.
Organizational Affiliation
Sapienza
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gaetano Tanzilli, Prof.
Organizational Affiliation
Sapienza
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marcello Dominici, MD
Organizational Affiliation
Division of Cardiology, Department of Interventional Cardiology, Santa Maria University Hospital, Terni, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sapienza University of Rome
City
Rome
ZIP/Postal Code
00161
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
25074252
Citation
Basili S, Tanzilli G, Raparelli V, Calvieri C, Pignatelli P, Carnevale R, Dominici M, Placanica A, Arrivi A, Farcomeni A, Barilla F, Mangieri E, Violi F. Aspirin reload before elective percutaneous coronary intervention: impact on serum thromboxane b2 and myocardial reperfusion indexes. Circ Cardiovasc Interv. 2014 Aug;7(4):577-84. doi: 10.1161/CIRCINTERVENTIONS.113.001197. Epub 2014 Jul 29.
Results Reference
derived

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Aspirin Reload Before Percutaneous Coronary Intervention: Reperfusion Indexes Evaluation.

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