Doubling the Maintenance Dose of Clopidogrel in Patients With High On-Clopidogrel Platelet Reactivity

150 mg Maintenance Dose of Clopidogrel in Patients With High On-Clopidogrel Platelet Reactivity After Elective Percutaneous Coronary Intervention

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00638326

Acronym

DOSER

Enrollment

500

Registered

2008-03-19

Start date

2008-03-31

Completion date

2010-03-31

Last updated

2010-03-23

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

Conditions

Ad Hoc Percutaneous Coronary Intervention, Stable Angina Pectoris

Keywords

Clopidogrel, thrombosis, Percutaneous Transluminal Coronary Angioplasty, stents

Brief summary

The purpose of the study is to determine whether administration of 150 mg clopidogrel is effective in reducing the one-year incidence of thromboischemic events in patients with high on-clopidogrel platelet reactivity compared to 75 mg clopidogrel after elective percutaneous coronary intervention.

Interventions

DRUGclopidogrel

150 mg maintenance dose (2 capsules of 75 mg clopidogrel) for 28 days followed by standard 75 mg clopidogrel for one year

DRUGclopidogrel plus placebo

75 mg maintenance dose (one capsule of 75 mg clopidogrel and one capsule placebo) for 28 days followed by standard 75 mg clopidogrel for one year

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

35 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Clopidogrel-naïve stable angina pectoris (CCS I-III) * Coronary angiography that reveals significant DE NOVO coronary stenosis (diameter stenosis greater than 50% in two independent projections) feasible for ad hoc stent implantation

Exclusion criteria

* Acute coronary syndrome (STEMI, NSTEMI or unstable angina) * Administration of clopidogrel/ticlopidine/coumarin in the past 6 weeks * Contraindication to antiplatelet therapy * Significant LM stenosis * PCI due to instent restenosis * Lesion located in bypass grafts * Stroke in past one year * Reduced life expectancy

Design outcomes

Primary

Measure	Time frame
Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation.	12 months

Secondary

Measure	Time frame
Academic Research Consortium (ARC) definite / probable stent thrombosis	12 months
Cardiac death and non-fatal myocardial infarction	12 months
Cardiac death or non-fatal myocardial infarction or ischemia-driven target vessel revascularisation or TIMI major/minor bleeding	12 months
5 microM ADP-induced platelet aggregation assessed by light transmission aggregometer	25 +/-2 days
VASP-PRI	25 +/-2 days

Countries

Hungary

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026