MedDataX Logo

Prasugrel 5mg Versus High Dose Clopidogrel in Clopidogrel Resistant Patients Aged ≥75 Years and/or Weighing <60 kg Post Percutaneous Coronary Intervention (PCI)

NCT ID: NCT01463150

Last Updated: 2012-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The use of dual antiplatelet therapy is considered standard of care in patients post percutaneous coronary intervention (PCI) with stenting. However, a significant proportion of patients is considered clopidogrel resistant and this resistance is shown to be accompanied by future adverse events. The aim of the study is to define in consecutive patients with acute coronary syndrome (ACS) undergoing PCI, those aged\>75years and/or weighted\<60 Kg with high on-clopidogrel platelet reactivity (Platelet Reactivity Units-PRU≥235) as estimated 24 hours post PCI with the VerifyNow assay. Those patients will be randomized after informed concent in 1:1 fashion to prasugrel 5 mg or clopidogrel 150mg daily. Platelet reactivity will be assessed at day 15 and then treatment crossover will be performed. At day 30 platelet reactivity will be determined as well.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Platelet Reactivity

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Platelet reactivity Clopidogrel Prasugrel

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Clopidogrel

Clopidogrel 150mg per day for 15 days

Group Type ACTIVE_COMPARATOR

Clopidogrel

Intervention Type DRUG

Clopidogrel 150mg per day for 15 days

Prasugrel

Prasugrel 5mg for 15 days

Group Type EXPERIMENTAL

Prasugrel

Intervention Type DRUG

Prasugrel 5mg per day for 15 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Clopidogrel

Clopidogrel 150mg per day for 15 days

Intervention Type DRUG

Prasugrel

Prasugrel 5mg per day for 15 days

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age ≥18 years old
2. Patients having PCI with stenting 24 hours prior randomization, meeting the following criteria :

* Acute coronary syndrome (unstable angina or myocardial infarction)
* TIMI risk score\>2
3. Platelet reactivity in PRU ≥235 24 hours post-PCI
4. Age≥75 years and/or weight\<60 Kg

4\. Informed consent obtained in writing

Exclusion Criteria

* A history of bleeding diathesis
* Chronic oral anticoagulation treatment
* Contraindications to antiplatelet therapy
* Known platelet function disorders
* PCI or coronary artery bypass surgery \< 3 months
* Unsuccessful PCI (residual stenosis \> 30% or flow \< Thrombolysis in myocardial infarction flow 3)
* Planned staged PCI in the next 30 days
* Hemodynamic instability
* hemodialysis
* Creatinine clearance \<25 ml/min
* inability to give informed consent
* High likelihood of being unavailable for the Day 30
* History of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 6 months.
* Other bleeding diathesis, or considered by investigator to be at high risk for bleeding on longterm antiplatelet therapy.
* Any previous history of ischemic stroke, transient ischemic attack, intracranial hemorrhage or disease (neoplasm, arteriovenous malformation, aneurysm).
* Thrombocytopenia (\<100.000 / μL) at randomization
* Anaemia (Hct \<30%) at randomization
* Polycythaemia (Hct \> 52%) at randomization
* Periprocedural IIb/IIIa inhibitor administration
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Patras

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dimitrios Alexopoulos

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cardiology Department Patras University Hospital

Rio, Achaia, Greece

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Greece

References

Explore related publications, articles, or registry entries linked to this study.

Alexopoulos D, Xanthopoulou I, Plakomyti TE, Theodoropoulos KC, Mavronasiou E, Damelou A, Hahalis G, Davlouros P. Pharmacodynamic effect of prasugrel 5 mg vs clopidogrel 150 mg in elderly patients with high on-clopidogrel platelet reactivity. Am Heart J. 2013 Jan;165(1):73-9. doi: 10.1016/j.ahj.2012.10.008. Epub 2012 Nov 14.

Reference Type DERIVED
PMID: 23237136 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PATRASCARDIOLOGY-7

Identifier Type: -

Identifier Source: org_study_id