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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Antonio Colombo, IRCCS San Raffaele
ClinicalTrials.gov Identifier:
NCT01526460
First received: September 14, 2011
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Platelet Dysfunction
Drug: Atorvastatin
Drug: Rosuvastatin
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by IRCCS San Raffaele:

Primary Outcome Measures:
  • Area Under the Aggregation Curve (AUC) measured with the Multiplate 5.0 Analyzer [ Time Frame: Evaluation of platelet reactivity (in terms of AUC) two time points. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Incidence of periprocedural myocardial infarction [ Time Frame: CK and CK-MB evaluated before the procedure and two time points up to 12 hours ] [ Designated as safety issue: No ]
    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.


Enrollment: 146
Study Start Date: August 2011
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Atorvastatin
Atorvastatin 80 mg
Drug: Atorvastatin
80 mg
Other Names:
  • TORVAST
  • TOTALIP
Active Comparator: Rosuvastatin
Rosuvastatin 40 mg
Drug: Rosuvastatin
40 mg
Other Name: CRESTOR
Placebo Comparator: No statin loading dose
No statin loading dose
Drug: Placebo
no statin loading dose
Other Name: NO STATIN DRUGS

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01526460

Locations
Italy
IRCCS San Raffaele Monte Tabor
Milan, Italy, 20132
Sponsors and Collaborators
IRCCS San Raffaele
Investigators
Principal Investigator: Antonio Colombo, MD IRCCS San Raffaele Monte Tabor
  More Information

No publications provided

Responsible Party: Antonio Colombo, MD, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT01526460     History of Changes
Other Study ID Numbers: STATIPLAT
Study First Received: September 14, 2011
Last Updated: March 5, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by IRCCS San Raffaele:
Platelet
Atorvastatin
Rosuvastatin
Multiplate
reactivity

Additional relevant MeSH terms:
Blood Platelet Disorders
Hematologic Diseases
Atorvastatin
Rosuvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 22, 2014