Influence of treatment adhesion to clopidogrel on platelet aggregation in subjects carrying coronary stent

Influence of treatment adhesion to clopidogrel on platelet aggregation in subjects carrying coronary stent: an interventional single centre randomised double-blinded open label trial with three parallel arms

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN85949729

Enrollment

225

Registered

2011-01-14

Start date

2010-04-01

Completion date

Unknown

Last updated

2020-10-26

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

Conditions

Coronary stenting Circulatory System Coronary disease

Interventions

Group 1: standard care 6 month follow-up, without electronic pillbox. Total visits: 3. Group 2: 6 months follow-up with double blinded electronic pillbox (MEMS®), usual care, without f

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adult patients greater than 18 years, either sex 2. Treated with clopidogrel (Plavix®) for greater than 6 months after coronary stent implantation (indication: stable/unstable angina or non-invasive functional test positive for myocardial ischaemia ) in the interventional cardiology department

Exclusion criteria

Exclusion criteria: 1. Heart failure classification according to New York Heart Association (NYHA) class III or IV 2. ST and non-ST elevation myocardial infarction (less than 1 month) 3. Platelets less than 100,000/l 4. Inflammatory diseases requiring prednisone treatment 5. Medical history of: 5.1. Acute or chronic thrombocytopenia 5.2. Ticlopidine allergy 5.3. Active gastric ulcer (less than 2 months) 5.4. Cerebral hemorrhage (less than 6 months) 5.5. Uncontrolled hypertension greater than or equal to 180/110 mmHg 5.6. Liver Insufficiency CHILD-score greater than or equal to 1 5.7. Bleeding diathesis 5.8. Pregnancy, breast feeding 5.9. Associated drug therapy with CYP2C19 inhibitors

Design outcomes

Primary

Measure	Time frame
Platelets aggregation (determined by the VASP assay, as index of platelet reactivity) at 6 months	—

Secondary

Measure	Time frame
1. Incidence of cardiovascular events, including: acute non-lethal myocardial infarction, stent thrombosis, cardiovascular mortality 2. Incidence of hemorrhagic complications 3. Drug adherence to clopidogrel using the MEMS® on a 6 months period. The adherence will be measured by 4 parameters: percentage of doses taken, taking adherence, percentage of drug holidays, persistence. 4. Influence of the CYP2C19 polymorphism on aggregation studies in the long term follow-up of patients after coronary stent implantation	—

Measure

Time frame

1. Incidence of cardiovascular events, including: acute non-lethal myocardial infarction, stent thrombosis, cardiovascular mortality 2. Incidence of hemorrhagic complications 3. Drug adherence to clopidogrel using the MEMS® on a 6 months period. The adherence will be measured by 4 parameters: percentage of doses taken, taking adherence, percentage of drug holidays, persistence. 4. Influence of the CYP2C19 polymorphism on aggregation studies in the long term follow-up of patients after coronary stent implantation

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Countries

Switzerland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 25, 2026