Evaluation of Platelet Function After Statin Loading Dose in Patients Before Percutaneous Coronary Intervention (STATIPLAT)
This study is currently recruiting participants.
Verified May 2012 by IRCCS San Raffaele
Sponsor:
IRCCS San Raffaele
Information provided by (Responsible Party):
Antonio Colombo, IRCCS San Raffaele
ClinicalTrials.gov Identifier:
NCT01526460
First received: September 14, 2011
Last updated: May 22, 2012
Last verified: May 2012
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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.
| Estimated Enrollment: | 240 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Atorvastatin
Atorvastatin 80 mg
|
Drug: Atorvastatin
80 mg
Other Names:
|
|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01526460
Contacts
| Contact: Antonio Colombo, MD | +39022643 ext 7331 | antonio.colombo@hsr.it |
| Contact: Cosmo Godino, MD | +39022643 ext 3752 | cosmo.godino@hsr.it |
Locations
| Italy | |
| IRCCS San Raffaele Monte Tabor | Recruiting |
| Milan, Italy, 20132 | |
| Contact: Antonio Colombo, MD +39022643 ext 7331 antonio.colombo@hsr.it | |
| Contact: Cosmo Godino, MD +39022643 ext 3752 cosmo.godino@hsr.it | |
| Principal Investigator: Antonio Colombo, MD | |
| Sub-Investigator: Cosmo Godino, MD | |
| Sub-Investigator: Alaide Chieffo, MD | |
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: | May 22, 2012 |
| 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 Hydroxymethylglutaryl-CoA Reductase Inhibitors Rosuvastatin Anticholesteremic Agents Hypolipidemic Agents |
Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013