Overview

Effect of Proton Pump Inhibitor on Residual Platelet Reactivity After Clopidogrel in Homogenous Genetic Strata

Status:
Unknown status

Trial end date:
2013-08-01

Target enrollment:
0

Participant gender:
All

Summary

This study aims to prospectively assess whether there is an interaction between genetic status in terms of 2C19 activity and residual platelet reactivity after clopidogrel intake in patients who underwent coronary stenting for elective, urgent or emergent intervention.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Università degli Studi di Ferrara

Treatments:

Clopidogrel
Dexlansoprazole
Lansoprazole
Proton Pump Inhibitors
Ticlopidine

Criteria

Inclusion Criteria: All comer patients undergoing PCI will be recruited on a consecutive
basis.

• Patients will undergo screening before or soon after PCI depending on their clinical
presentation as follows:

- STEMI patients will receive upstream treatment with 600 mg clopidogrel before PCI and
will undergo screening for 2C19 status within 24 hours after treatment. Randomization
will occur immediately thereafter.

- Stable and NSTEACS patients will be treated upstream with 600 mg clopidogrel and will
undergo screening either before PCI or soon after (within 6 hours) revascularisation.
In both scenarios randomization will occur immediately after the genotype status is
known without any additional delay.

Exclusion Criteria:

1. Patients who can not give informed consent or have a life expectancy of < 1 year

2. Ongoing bleeding or bleeding diathesis or increase bleeding risk or history of
bleeding in the last 2 months

3. Age > 90

4. Previous stroke or TIA or any intracranial pathology

5. Major surgery or trauma within the previous six weeks

6. Platelet count < 100.000 per cubic mm or HCT ,33% or Hb < 11 gm/dL

7. Subjects with an allergy or intolerance to prasugrel or to clopidogrel

8. Planned elective cardiac or non-cardiac surgery within 1 month.

9. Current or planned therapy with coumadin anticoagulation.