Aspirin Reload Before Percutaneous Coronary Intervention: Reperfusion Indexes Evaluation.
Condition: Coronary Arteriosclerosis
MeSH terms: Arteriosclerosis; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional
Phase: Phase 4

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%).
    

Intervention name(s): Aspirin
Intervention type(s): Drug
Intervention description(s): Aspirin 325 mg
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: PCI; Aspirin; Reload