Evaluation of Platelet Function After Statin Loading Dose in Patients Before Percutaneous Coronary Intervention

Platelet Dysfunction Clinical Trial

— STATIPLAT  

Official title:

Prospective, Randomized, Single Center, Open Label Study Designed to Evaluate the Effect on Platelet Reactivity in Response to High Doses of Atorvastatin or Rosuvastatin Administered Before Percutaneous Coronary Intervention (PCI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01526460
• Other study ID #: STATIPLAT
• Status: Completed
• Phase: Phase 2
• First received: September 14, 2011
• Last updated: March 5, 2014
• Start date: August 2011
• Est. completion date: February 2014

Study information

• Verified date: March 2014
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effect of a loading dose of two different statins on platelet reactivity (atorvastatin, metabolized by CYP3A4, and rosuvastatin, which is rather independent of this enzyme)in patients at least 5 days in therapy with aspirin and clopidogrel (with or without an undergoing treatment with statins) undergoing PCI for coronary disease with chronic stable angina and/or evidence of inducible myocardial ischemia.

Description:

An initial assessment of platelet reactivity in response to the TRAP (thrombin receptor agonist), ADP and arachidonic acid (respectively, indicative of the response to clopidogrel and aspirin) will be performed with impedance aggregometry (Multiplate® analyzer system). Patients with a increased residual platelet reactivity to ADP test (AUC > 47) will receive a different antiplatelet therapy and will then be excluded from the study, the other will be randomized to 3 groups of treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age: 18-75 years

• Patients with chronic stable angina

• Patients with coronary artery disease or with de novo stent restenosis of native vessels.

• Patients who are able to understand the significance of this study and to adhere to recruitment by signing the informed consent.

Exclusion Criteria:

• Acute Coronary Syndromes with an enzymatic movement (STEMI, NSTEMI).

• Allergy or intolerance to atorvastatin, rosuvastatin, aspirin, clopidogrel.

• Altered basal level of transaminase or CPK.

• Patient with history of hepatitis-acute/chronic.

• Patients already receiving high-dose statins.

• Contraindications to antiplatelet therapy.

• Patients with acute inflammatory disease and/or underlying chronic (hepatitis, pneumonia, urinary tract, rectum ulcerative colitis etc.).

• Patients with anemia (haemoglobin <8.5 mg/dl), leukocytosis (WBC> 12.000 mm3), leukopenia (WBC <3000 mm3), platelet count <100.000; hypersplenism.

• Patients with malignant disease.

• Patients enrolled in other studies not yet completed.

• Patients with known allergy / intolerance to statins.

• Pregnant women and women who are breastfeeding.

• Patients with myopathy (muscle pain and unexplained repeated)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Platelet Disorders
• Platelet Dysfunction

Intervention

Drug:
• Atorvastatin
80 mg
• Rosuvastatin
40 mg
• Placebo
no statin loading dose

Locations

Country	Name	City	State
Italy	IRCCS San Raffaele Monte Tabor	Milan

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Aggregation Curve (AUC) measured with the Multiplate 5.0 Analyzer	Evaluation of the effect of a loading dose (LD) of two different statins on platelet reactivity (atorvastatin and rosuvastatin) in terms of difference between AUC value before statin LD and after 12 hrs statin LD. The Area Under the Aggregation Curve (AUC) will be measured with the Multiplate 5.0 system.	Evaluation of platelet reactivity (in terms of AUC) two time points.	No
Secondary	Incidence of periprocedural myocardial infarction	To evaluate if the loading dose of statin prevent the periprocedural myocardial damage measured by CK and CK-MB The measurments will be done once before the procedure and at 6 and 12 hours after.	CK and CK-MB evaluated before the procedure and two time points up to 12 hours	No