Pharmacogenetics of Clopidogrel in Acute Coronary Syndromes (PHARMCLO)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03347435 |
Recruitment Status :
Terminated
(Ethics Committe decision)
First Posted : November 20, 2017
Last Update Posted : November 20, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Coronary Syndromes | Genetic: genetic tests for CYP2C19*2, CYP2C19*17 and ABCB1 3435 Other: clinical algorithm | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 889 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Pharmacogenetics of Clopidogrel in Acute Coronary Syndromes |
Study Start Date : | June 2013 |
Actual Primary Completion Date : | March 2015 |
Actual Study Completion Date : | March 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: Genotype/ phenotype guided group
The patients randomized to the genotype/phenotype guided group undergo genetic tests for CYP2C19*2, CYP2C19*17 and ABCB1 3435 genetic variants immediately after diagnosis of ACS and receive one of the ADP receptor antagonists (clopidogrel/prasugrel/ticagrelor) on the basis of an algorithm that consider genetic and clinical variables.
|
Genetic: genetic tests for CYP2C19*2, CYP2C19*17 and ABCB1 3435
The CYP2C19*2 (10q24.1-q24.3; rs4244285), CYP2C19*17 (10q24.1-q24.3; rs12248560) and ABCB1 3435 (7q21.1; rs1045642) genetic variants will be genotyped using an ST Q3 system. The conventional genotyping methods so far used for diagnostic purposes will not be used in this study because appropriate labs may not be readily available and the processing time is prohibitive. Q3 is a compact platform enabling the classical laboratory analysis of DNA by means of real-time PCR. The Q3 has been designed as a low entry-cost, portable, point-of-care instrument for foolproof use by unskilled personnel. Antiplatelet therapy will be choose on the basis of clinical and genetic algorithm. |
Active Comparator: phenotype only guided group
The patients randomized to the phenotype only guided group receive clopidogrel or prasugrel or ticagrelor on the basis of the standard of care on the basis of clinical algorithm alone.
|
Other: clinical algorithm
Antiplatelet therapy will be choose on the basis of clinical algorithm alone |
- Composite of cardiovascular death, non fatal myocardial infarction, stroke and BARC-defined major bleeding events 3 to 5. [ Time Frame: 12 months ]The primary endpoint will be the composite of cardiovascular death, non fatal myocardial infarction, stroke and BARC-defined major bleeding events 3 to 5 at 12 months follow-up.
- occurrence of definite or probable stent thrombosis. [ Time Frame: 12 months ]The secondary endpoint variable will be the occurrence of definite or probable stent thrombosis at 12 months follow-up.
- cardiovascular death [ Time Frame: 12 months ]individual components of primary endpoint at 12 months follow-up
- non fatal myocardial infarction [ Time Frame: 12 months ]individual components of primary endpoint at 12 months follow-up
- stroke [ Time Frame: 12 months ]individual components of primary endpoint at 12 months follow-up
- BARC-defined major bleeding events 3 to 5 [ Time Frame: 12 months ]individual components of primary endpoint at 12 months follow-up

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of ACS (STE-ACS or NSTE-ACS) during the index hospitalisation
- Age >18 years
- Ability to sign the informed consent form
- Ability to attend scheduled visits
Exclusion Criteria:
- Cognitive or other causes of an inability to provide informed consent or follow study procedures
- Any contraindication to the use of ADP P2Y12 inhibitors
- Life expectancy <1 year
- Thrombolytic therapy within the previous 24 hours
- Known ABCB1, CYP2C19 *2 orCYP2C19 *17 genotype

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): NCT03347435
Italy | |
Ospedale Ramazzini | |
Carpi, Modena, Italy, 41012 | |
Ospedale di Vaio | |
Fidenza, Parma, Italy, 43036 | |
Azienda Ospedaliero Universitaria di Parma | |
Parma, Italy, 43123 | |
Ospedale Guglielmo da Saliceto | |
Piacenza, Italy, 29121 |
Principal Investigator: | Diego Ardissino, MD | Azienda Ospedaliero-Universitaria di Parma |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Diego Ardissino, Director of Division of Cardiology, Azienda Ospedaliero-Universitaria di Parma |
ClinicalTrials.gov Identifier: | NCT03347435 |
Other Study ID Numbers: |
11210 |
First Posted: | November 20, 2017 Key Record Dates |
Last Update Posted: | November 20, 2017 |
Last Verified: | November 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
clopidogrel pharmacogenetics antiplatelet therapy acute coronary syndromes |
Acute Coronary Syndrome Syndrome Disease Pathologic Processes |
Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |