Pharmacodynamic Comparison of Rosuvastatin Versus Atorvastatin on Platelet Reactivity in Patients With Coronary Artery Disease on Dual Antiplatelet Therapy With New P2Y12 Inhibitors (Trial gRANADa)

NCT02030054 | Unknown Phase 4

• 1 other identifier: 060114
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Statin interference has been suggested among the mechanisms of reduction of the antiplatelet effect of clopidogrel. The purpose of this study is to evaluate pharmacodynamic effects of rosuvastatin and atorvastatin on platelet reactivity in patients with coronary artery disease undergone double antiplatelet therapy with new P2Y12 inhibitors. This is a single-center, prospective, randomized, crossover study conducted in the Department of Heart and Great Vessels "Attilio Reale", Sapienza University, Rome, Italy. All consecutive patients undergone PTCA in our institution in the period between July 2013 and December 2013 will be eligible to be enrolled. Patients will be offered to participate to the trial at time of 1-month post-angioplasty follow-up visit.patients receiving dual antiplatelet therapy (prasugrel 10 mg or brilique 90 mg x 2 plus aspirin 100 mg) after percutaneous coronary intervention. Patients were randomly assigned to rosuvastatin (20 mg day) or atorvastatin (40 mg day) for 30 days. After 1-week wash-out period to avoid any carryover effect, cross-over was performed, and patients were switched to the other drug which was continued for 30 days. Platelet function will be evaluated using a validated method: the VerifyNow System (Accumetrics Inc., San Diego, CA), which is a point-of-care turbidimetry-based optical detection system that measures platelet-induced aggregation. Platelet function will be measured with the VerifyNow P2Y12 test at baseline and after 30 days from rosuvastatin or atorvastatin administration. Platelet reactivity will be expressed in P2Y12 reaction units (PRU). PRU values \>208 are suggestive of high platelet reactivity.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Assessment of platelet reaction units

  Absolute changes in platelet reactivity (expressed as P2Y(12) reaction units by the point-of-care VerifyNow assay \[Accumetrics, San Diego, California\]

  After 30 days of treatment with each drug

Secondary Outcomes (1)

• Frequency of high platelet reactivity

  After 30 days of treatment with each drug

Study Arms (2)

atorvastatin

ACTIVE COMPARATOR

Patients were randomly assigned to atorvastatin (40 mg day) or rosuvastatin (20 mg day) for 30 days. After 1-week wash-out period to avoid any carryover effect, cross-over was performed, and patients were switched to the other drug which was continued for 30 days.

Drug: Atorvastatin; Drug: Rosuvastatin

rosuvastatin

ACTIVE COMPARATOR

Patients were randomly assigned to atorvastatin (40 mg day) or rosuvastatin(20 mg day) for 30 days. After 1-week wash-out period to avoid any carryover effect, cross-over was performed, and patients were switched to the other drug which was continued for 30 days.

Drug: Atorvastatin; Drug: Rosuvastatin

Interventions

Atorvastatin DRUG

Patients were randomly assigned to atorvastatin (40 mg day) for 30 days. After 1-week wash-out period to avoid any carryover effect, cross-over was performed, and patients were switched to the other drug which was continued for 30 days.

Also known as: torvast, totalip

atorvastatin; rosuvastatin

Rosuvastatin DRUG

Patients were randomly assigned to rosuvastatin (20 mg day) for 30 days. After 1-week wash-out period to avoid any carryover effect, cross-over was performed, and patients were switched to the other drug which was continued for 30 days.

Also known as: crestor, provisacor,

atorvastatin; rosuvastatin

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Angiographically-proven coronary artery disease;
• Able to understand and willing to sign the informed CF;
• Stable clinical condition;
• treatment with dual antiplatelet therapy (with P2Y12 inhibitors);

You may not qualify if:

• Other drugs or medications that affect CYP mediated drug metabolism;
• Allergy or adverse reactions to administered drugs;

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Sapienza Univeristy of Rome

Rome, Italy, 00166, Italy

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Atorvastatin; Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines

Central Study Contacts

MD MARINA POLACCO, medicine

CONTACT

+393333347960; dott.mpolacco@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 6, 2014
• First Posted: January 8, 2014
• Study Start: January 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: September 1, 2015
• Last Updated: December 4, 2014

Record last verified: 2014-12

Locations

IT (1)