An Exploratory, Multi-center, Open-Label, Single-Arm study to evaluate the Discontinuation Effect of Clopidogrel After Drug Eluting Stent (DECADES) on Inflammatory and Platelet Activation Markers in Subjects Who Are Receiving Low Dose Acetylsalicylic Acid (ASA)

An Exploratory, Multi-center, Open-Label, Single-Arm study to evaluate the Discontinuation Effect of Clopidogrel After Drug Eluting Stent (DECADES) on Inflammatory and Platelet Activation Markers in Subjects Who Are Receiving Low Dose Acetylsalicylic Acid (ASA) - CV149-208

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON31060

Enrollment

Registered

2007-09-03

Start date

2007-10-31

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

subjects with one or more drug eluting stents

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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).	—

Countries

Netherlands

Outcome results