NCT01526460

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 14, 2011

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 3, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

March 6, 2014

Status Verified

March 1, 2014

Enrollment Period

2.5 years

First QC Date

September 14, 2011

Last Update Submit

March 5, 2014

Conditions

Platelet Dysfunction

Keywords

PlateletAtorvastatinRosuvastatinMultiplatereactivity

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (1)

  • Incidence of periprocedural myocardial infarction

    CK and CK-MB evaluated before the procedure and two time points up to 12 hours

Study Arms (3)

Atorvastatin

ACTIVE COMPARATOR

Atorvastatin 80 mg

Drug: Atorvastatin

Rosuvastatin

ACTIVE COMPARATOR

Rosuvastatin 40 mg

Drug: Rosuvastatin

No statin loading dose

PLACEBO COMPARATOR

No statin loading dose

Drug: Placebo

Interventions

AtorvastatinDRUG

80 mg

Also known as: TORVAST, TOTALIP
Atorvastatin
RosuvastatinDRUG

40 mg

Also known as: CRESTOR
Rosuvastatin
PlaceboDRUG

no statin loading dose

Also known as: NO STATIN DRUGS
No statin loading dose

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS San Raffaele Monte Tabor

Milan, 20132, Italy

Location

MeSH Terms

Interventions

AtorvastatinRosuvastatin Calcium

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipidsSulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidines

Study Officials

  • Antonio Colombo, MD

    IRCCS San Raffaele Monte Tabor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 14, 2011

First Posted

February 3, 2012

Study Start

August 1, 2011

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

March 6, 2014

Record last verified: 2014-03

Locations

IT(1)