E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Biomarkers of inflammation and platelet activation |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10058542 |
E.1.2 | Term | Anti-platelet antibody |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess if the withdrawal of clopidogrel 12 months after DES implantation leads to an increase in the level of soluble CD40 Ligand over a four weeks follow-up period. |
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E.2.2 | Secondary objectives of the trial |
To assess the withdrawal of clopidogrel 12 months after DES implantation on: • Laboratory biomarkers: - Plasma soluble P-selectin - High sensitivity C-reactive protein (hs-CRP) • Safety measures: Adverse Events (AE) / Serious Adverse Events (SAE) reports. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Subjects who signed the informed consent prior to any study-related procedures. 2) Subjects with one or more drug-eluting stents of any type who are coming to the end of their 12 months of clopidogrel (75 mg daily) treatment. 3) Subjects receiving low dose ASA. 4) Subjects receiving a statin. 5) 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. 6) Subjects with no clinical history of diabetes mellitus. 7) Men and women, ages 18 years or older. |
|
E.4 | Principal 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. 7) Currently taking another investigational study medication or has taken investigational study medication within 30 days prior to screening visit . 8) Subjects who would be likely to require prohibited concomitant therapy during the study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary Biomarkers
Blood will be drawn to assess the levels of the soluble CD40 Ligand biomarker at each visit.
Secondary biomarker measurements are: • Plasma soluble P-selectin • hs-CRP Blood will be drawn at each visit.
Safety
Safety will be evaluated during the entire study period of a subject by reporting of adverse events (AEs) and serious adverse events (SAEs), including reporting of any bleeding and locally available laboratory tests performed because of an adverse event. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 6 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |