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Trial record 62 of 507 for:    ASPIRIN AND P2

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) (gRANADa)

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ClinicalTrials.gov Identifier: NCT02030054
Recruitment Status : Unknown
Verified December 2014 by Polacco Marina, University of Roma La Sapienza.
Recruitment status was:  Not yet recruiting
First Posted : January 8, 2014
Last Update Posted : December 4, 2014
Sponsor:
Information provided by (Responsible Party):
Polacco Marina, University of Roma La Sapienza

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.


Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Atorvastatin Drug: Rosuvastatin Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pharmacodynamic Comparison of Rosuvastatin Versus Atorvastatin on Platelet Reactivity in Patients With Coronary Artery Disease on Dual Antiplatelet Therapy With New P2Y12 Inhibitors
Study Start Date : January 2015
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: atorvastatin
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
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.
Other Name: torvast, totalip

Drug: Rosuvastatin
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.
Other Name: crestor, provisacor,

Active Comparator: rosuvastatin
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
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.
Other Name: torvast, totalip

Drug: Rosuvastatin
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.
Other Name: crestor, provisacor,




Primary Outcome Measures :
  1. Assessment of platelet reaction units [ Time Frame: After 30 days of treatment with each drug ]
    Absolute changes in platelet reactivity (expressed as P2Y(12) reaction units by the point-of-care VerifyNow assay [Accumetrics, San Diego, California]


Secondary Outcome Measures :
  1. Frequency of high platelet reactivity [ Time Frame: After 30 days of treatment with each drug ]
    Frequency of high platelet reactivity with the 2 study treatments (as defined by a Platelet Reaction Unit value>208



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02030054


Contacts
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Contact: MD MARINA POLACCO, medicine +393333347960 dott.mpolacco@gmail.com

Locations
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Italy
Sapienza Univeristy of Rome Not yet recruiting
Rome, Italy, 00166
Contact: MD MARINA POLACCO, medicine    +393333347960    dott.mpolacco@gmail.com   
Principal Investigator: MD Marina Polacco, medicine         
Sponsors and Collaborators
University of Roma La Sapienza

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Responsible Party: Polacco Marina, MD, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT02030054     History of Changes
Other Study ID Numbers: 060114
First Posted: January 8, 2014    Key Record Dates
Last Update Posted: December 4, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Atorvastatin
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors