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Trial record 1 of 1 for:    NCT02508116
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Assessment of Prospective CYP2C19 Genotype Guided Dosing of Anti-Platelet Therapy in Percutaneous Coronary Intervention (ADAPT)

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ClinicalTrials.gov Identifier: NCT02508116
Recruitment Status : Completed
First Posted : July 24, 2015
Results First Posted : November 7, 2018
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
Sony Tuteja, University of Pennsylvania

Brief Summary:
This is a randomized, prospective, open label study to determine the cost-effectiveness of genotype-guided antiplatelet therapy. Patients undergoing percutaneous intervention (PCI) with stent implantation, will be randomized either to genotype guided dosing of antiplatelet therapy or usual care. The study utilizes a novel genotyping device, SpartanRx, to determine CYP2C19 genotypes from a buccal swab sample with 1 hour turnaround time.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Cardiovascular Diseases Genetic: CYP2C19 genotyping Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 509 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients undergoing PCI are randomized to genotype guided antiplatelet therapy vs. usual care.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Assessment of Prospective CYP2C19 Genotype Guided Dosing of Anti-Platelet Therapy in Percutaneous Coronary Intervention (ADAPT)
Actual Study Start Date : November 2014
Actual Primary Completion Date : May 2017
Actual Study Completion Date : August 2017

Arm Intervention/treatment
Experimental: CYP2C19 Genotype guided
Prospective CYP2C19 genotyping to decide antiplatelet therapy.
Genetic: CYP2C19 genotyping
The study utilizes a genotyping device, SpartanRx™ (Spartan Bioscience, Ottawa, Canada) that provides identification of a patient's CYP2C19 *2, *3, and *17 genotypes determined from genomic DNA from a buccal swab sample with 1 hour turnaround time
Other Name: SpartanRx

No Intervention: Control group
Antiplatelet therapy will be decided based on usual care



Primary Outcome Measures :
  1. The Number (Percentage) of Participants Receiving Prasugrel/Ticagrelor [ Time Frame: for up to 7 days after PCI ]
    The number (percentage) of participants receiving prasugrel/ticagrelor in each randomized arm


Secondary Outcome Measures :
  1. Number of Participants With Drug Orders in Agreement With the Genotype-guided Recommendations [ Time Frame: for up to 7 days after PCI ]
    Agreement to suggested treatment recommendations based on genotype. The agreement rate was defined as the number of participants in genotyped group with loss of function variants that received prasugrel or ticagrelor + the number of participants without these variants that received clopidogrel divided by the total number in this group.

  2. Number of Participants With Major Cardiac Events [ Time Frame: 1 year ]
    major cardiac events defined as occurrence of first myocardial infarction, ischemic stroke, cardiovascular death, stent thrombosis, or need for urgent revascularization

  3. Number of Participants With Bleeding Events [ Time Frame: 1 year ]

    major bleeding events defined by the Bleeding Academic Research Consortium (BARC) type 3 or 5.

    Type 3= Overt bleeding requiring: blood transfusion, surgical intervention or intravenous vasoactive agents; cardiac tamponade; intracranial hemorrhage; intraocular bleeding.

    Type 5= fatal bleeding




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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female subjects, ≥18 to ≤80 years at time of study
  2. Status post PCI with stent implantation requiring antiplatelet therapy
  3. Willingness to comply with all study-related procedures

Exclusion Criteria:

  1. Pending imminent surgery placing patients at increased risk for bleeding with prasugrel or ticagrelor.
  2. History of intracranial hemorrhage, TIA, and stroke
  3. Active bleeding
  4. Need for long-term anticoagulation (i.e. warfarin, dabigatran, rivaroxaban, apixaban, edoxaban, or lovenox).
  5. Current or prior (within the past four weeks) treatment with voraxapar (Zontivity).
  6. Severe renal or hepatic impairment
  7. Treating physician does not want subject to participate
  8. Drug allergy to clopidogrel, prasugrel or ticagrelor.

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): NCT02508116


Locations
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United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Sony Tuteja, PharmD, MS University of Pennsylvania
Principal Investigator: Jay S Giri, MD University of Pennsylvania
  Study Documents (Full-Text)

Documents provided by Sony Tuteja, University of Pennsylvania:
Study Protocol  [PDF] June 1, 2017
Statistical Analysis Plan  [PDF] December 1, 2017

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sony Tuteja, Research Associate, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02508116    
Other Study ID Numbers: 820899
First Posted: July 24, 2015    Key Record Dates
Results First Posted: November 7, 2018
Last Update Posted: November 7, 2018
Last Verified: October 2018
Keywords provided by Sony Tuteja, University of Pennsylvania:
pharmacogenetics
clopidogrel
genotype
Additional relevant MeSH terms:
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Cardiovascular Diseases
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Vascular Diseases