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Bedside Genetic or Pharmacodynamic Testing to Prevent Periprocedural Myonecrosis During PCI (ONSIDE TEST)

NCT01930773 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2018-12-24

No results posted yet for this study

Summary

Patients undergoing percutaneous coronary intervention with a residual high platelet reactivity despite oral clopidogrel are at increased risk of ischaemic complications. The strategies to overcome the issue consist of switch to a more potent antiplatelet medications including prasugrel or ticagrelor. Economic constrains of many countries still do not allow wide reimbursement of newer antiplatelet agents. Therefore a strategy to personalise treatment according to genotype and phenotype characteristics of the patient may provide an attractive solution combining high clinical efficacy with low budget impact.

Conditions

  • Stable Angina

Interventions

DEVICE

Genotyping

Patients harboring CYP2C19 \*2 alleles receive 60 mg prasugrel for PCI, while non-carriers receive 600 mg clopidogrel if not pretreated with clopidogrel.

DEVICE

Phenotyping

Patients having high on-treatment platelet reactivity (HPR: greater than 208 PRU) receive 60 mg prasugrel loading dose (LD), others continue clopidogrel for PCI.

Sponsors & Collaborators

  • Polish Cardiac Society

    collaborator OTHER

  • University of Pecs

    collaborator OTHER

  • Medical University of Warsaw

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2019-03-31
Completion
2019-09-30

Countries

  • Hungary
  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01930773 on ClinicalTrials.gov