Assessing Platelet Inhibitory Response to Clopidogrel – Feasibility, Safety and Cost Analysis of a Tailored Platelet Inhibition Strategy for Elective PCI Patients - Plavix and Prasugrel

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-018435-18-GB

Enrollment

200

Registered

2010-03-18

Start date

2010-05-21

Completion date

Unknown

Last updated

2012-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

To investigate the feasibility, safety and cost of using the platelet assay VerifyNow-P2Y12 to guide optimal P2Y12 platelet inhibition in patients undergoing elective PCI, compared with standard treatment, at a UK tertiary referral cardiology centre.

Interventions

Trade Name: Prasugrel (Efient) Product Name: Prasugrel Pharmaceutical Form: Tablet Trade Name: Clopidogrel (Plavix) Product Name: Clopidogrel (Plavix) Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age >18 Able to consent Elective PCI Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Contraindication to clopidogrel, aspirin or prasugrel Weight 75 Pregnancy Breast-feeding women Warfarin

Design outcomes

Primary

Measure	Time frame
Main Objective: To study platelet activity after implantation of coronary stents using the bed-side VerifyNow test. We want to determine if a more tailored individualised approach to post-procedure blood thinners (through weekly blood tests to measure the stickiness of blood after the coronary stent procedure and dose changes / treatment changes to blood thinner tablets) is more effective than standard care (blood thinners prescribed as per national guidelines). We hypothesise that the average platelet inhibition in patients with a tailored approach will be greater than those who receive standard care as per current national guidelines.;Secondary Objective: •Cost analysis difference between standard and tailored groups - Total cost to achieve optimal platelet inhibition in 100 patients •Percentage of responders at each stage of the tailored protocol •Safety data (MACE: stent thrombosis rate / myocardial infarction / ACS / stroke / TIA / major bleed at 6 months and 1 year) between standard and tailored groups •Differences in platelet assay predictive power in detecting responders / nonresponders ;Primary end point(s): Difference in mean platelet inhibition at day 28 between standard and tailored protocols	—

Measure

Time frame

Main Objective: To study platelet activity after implantation of coronary stents using the bed-side VerifyNow test. We want to determine if a more tailored individualised approach to post-procedure blood thinners (through weekly blood tests to measure the stickiness of blood after the coronary stent procedure and dose changes / treatment changes to blood thinner tablets) is more effective than standard care (blood thinners prescribed as per national guidelines). We hypothesise that the average platelet inhibition in patients with a tailored approach will be greater than those who receive standard care as per current national guidelines.;Secondary Objective: •Cost analysis difference between standard and tailored groups - Total cost to achieve optimal platelet inhibition in 100 patients •Percentage of responders at each stage of the tailored protocol •Safety data (MACE: stent thrombosis rate / myocardial infarction / ACS / stroke / TIA / major bleed at 6 months and 1 year) between standard and tailored groups •Differences in platelet assay predictive power in detecting responders / nonresponders ;Primary end point(s): Difference in mean platelet inhibition at day 28 between standard and tailored protocols

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026