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Evaluation of Platelet Function After Statin Loading Dose in Patients Before Percutaneous Coronary Intervention - Trial NCT01526460

Access comprehensive clinical trial information for NCT01526460 through Pure Global AI's free database. This Phase 2 trial is sponsored by IRCCS San Raffaele and is currently Completed. The study focuses on Platelet Dysfunction. Target enrollment is 146 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

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NCT01526460
Phase 2
Completed
drug
Trial Details
ClinicalTrials.gov โ€ข NCT01526460
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Evaluation of Platelet Function After Statin Loading Dose in Patients Before Percutaneous Coronary Intervention
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)

Study Focus

Platelet Dysfunction

Atorvastatin

Interventional

drug

Sponsor & Location

IRCCS San Raffaele

Milan, Italy

Timeline & Enrollment

Phase 2

Aug 01, 2011

Feb 01, 2014

146 participants

Primary Outcome

Area Under the Aggregation Curve (AUC) measured with the Multiplate 5.0 Analyzer

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.

ICD-10 Classifications

Qualitative platelet defects
Antithrombotic drugs [platelet-aggregation inhibitors]
Essential (haemorrhagic) thrombocythaemia
Other thrombophilia
Haemorrhagic disorder due to circulating anticoagulants

Data Source

ClinicalTrials.gov

NCT01526460

Non-Device Trial