Primary Objective: To assess whether the withdrawal of clopidogrel 12 months after Drug Eluting Stent (DES) implantation leads to an increase in markers of inflammation and platelet activation.Secondary Objectives: To assess the withdrawal of…
ID
Source
Brief title
Condition
- Coronary artery disorders
- Vascular disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Assess the mean change in the level of soluble CD40 Ligand over a four week
follow up period following withdrawal of clopidogrel after a 12 month treatment
period.
Secondary outcome
1. Changes in levels of high sensitivity C-reactive protein (hs-CRP) and plasma
soluble P-selectin.
2. Safety (evaluated by Adverse Event/Serious Adverse Event (AE/SAE) reports).
Background summary
Beginning in late 2006, there has been increasing awareness of an increased
incidence of stent thrombosis occurring many months after implantation of DES.
Although the exact frequency of this event remains controversial and the cause
may be multifactorial, enough instances have been associated with premature
discontinuation of effective antiplatelet therapy with ASA and clopidogrel that
the American Heart Association et al. issued an advisory on 16 January 2007
recommending that *patients who have had drug eluting stents inserted to prop
open blocked coronary arteries should continue to take medications to reduce
the risk of blood clots for at least one year after the stent is inserted*.
This recommendation has been echoed by other professional cardiology
associations in North America and Europe.
Therefore this study has been developed to evaluate the effect of clopidogrel
withdrawal 12 months after DES.
Study objective
Primary Objective: To assess whether the withdrawal of clopidogrel 12 months
after Drug Eluting Stent (DES) implantation leads to an increase in markers of
inflammation and platelet activation.
Secondary Objectives:
To assess the withdrawal of clopidogrel 12 months after DES implantation on:
• Laboratory biomarkers: Plasma soluble P-selectin, High selective C-reactive
protein (hs-CRP)
• Safety measures: Adverse Events (AE) / Serious Adverse Events (SAE) reports.
Study design
Exploratory, multi-center, open-label, single-arm study. Patients will have a
screening visit at the end of their 12 months of clopidogrel treatment and have
4 follow-up visits in 4 weeks.
Study burden and risks
This is an exploratory study. Subjects will be treated as per routine practice,
having their clopidogrel treatment withdrawn 12 months after its initiation at
the time of DES implantation. ASA monotherapy will be continued. The risks to
the study subjects are solely those associated with routine weekly blood draws
over a period of 4 weeks. There will be a total of 5 blood draws during the
subject*s participation in the study.
Vijzelmolenlaan 9
3440 AM Woerden
Nederland
Vijzelmolenlaan 9
3440 AM Woerden
Nederland
Listed location countries
Age
Inclusion criteria
1. Subjects with one or more sirolimus or paclitaxel drug-eluting stents who are coming to the end of their 12 months of clopidogrel (75 mg daily) treatment.
2. Subjects receiving low dose ASA.
3. Subjects receiving a statin.
4. Current medication regimen (including ASA and statins) must have been stable for three (3) months, i.e. no initiation of new prescription medication or change in dosage of any previously initiated medication within three (3) months of entering this study.
5. Subjects with no clinical history of diabetes mellitus.
Exclusion criteria
1. Subjects with a clinical history of diabetes mellitus.
2. History of alcohol or substance abuse within the past 12 months.
3. Any condition the Investigator believes would interfere with evaluation of the subject or which could put the subject at undue risk.
4. Uncontrolled hypertension (systolic blood pressure >180mmHg or diastolic
>100mmHg) at screening.
5. Intolerance or contraindication to ASA or statins.
6. Current use or use within the past 3 months of oral anticoagulants or dipyridamole or oral glucocorticoids.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL18236.078.07 |
| Other | volgt, aanvraag loopt |