E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Coronary artery disease previously treated with coronary stenting |
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E.1.1.1 | Medical condition in easily understood language |
Coronary artery disease is caused by plaque building up along the inner walls of the arteries of the heart, which narrow the arteries and reduces blood flow to the heart. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10011078 |
E.1.2 | Term | Coronary artery disease |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10023024 |
E.1.2 | Term | Ischaemic heart disease |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
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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 |
The overall study aim is to determine whether aspirin is required to achieve full platelet inhibition in patients with coronary artery disease who are also receiving ticagrelor. We will investigate this by comparing the pharmacodynamic effects of aspirin + ticagrelor (ASP + TIC) and ticagrelor alone (TIC) on platelets from patients allocated at random to the intervention.
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E.2.2 | Secondary objectives of the trial |
We will also compare the pharmacodynamic effects of ticagrelor (as aspirin + ticagrelor and as ticagrelor alone) with the effects of other current anti-platelet treatment regimens (aspirin + clopidogrel and aspirin + prasugre and aspirin alone). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. 1. Patient is treated with dual antiplatelet therapy comprising aspirin and any other P2Y12 blocker such as clopidogrel, prasugrel or ticagrelor 2. The patient is scheduled to stop dual antiplatelet therapy and continue with aspirin monotherapy.
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E.4 | Principal exclusion criteria |
1. Contraindication to dual antiplatelet therapy. 2. Interruption of dual antiplatelet therapy because of bleeding events or increased bleeding risk. 3. Contraindications to the use of ticagrelor. 4. Pregnant and or lactating women. 5. Women with child bearing potential (i.e. not sterilised or not post menopausal) who are unwilling to use contraception. 6. Men with a spouse or partner with child bearing potential unless the participant has agreed to use condoms.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome will be defined as the maximum amplitude of the light transmission aggregation response of platelet rich plasma (PRP) to TRAP6 expressed as a % of the absolute difference in light transmission between PRP and platelet poor plasma. This assay measures the ability of platelets to aggregate when exposed to the aggregation promoting agent TRAP. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
This test will be performed on all participants at each study visit. |
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E.5.2 | Secondary end point(s) |
Secondary outcome measures include: 1. Light transmission aggregation responses to collagen and to ADP, arachidonic acid and the thromboxane (TP) receptor agonist U46619. This assay measures the ability of platelets to aggregate when exposed to the aggregation promoting agents collagen, ADP, arachidonic acid and U46619. 2. Flow cytometry to quantify surface CD62P expression and PAC-1 binding before and after activation with collagen and TRAP6. This assay measures the exposure of surface activation markers. 3. Plasma concentrations of soluble CD40 ligand (sCD40L) and thromboxane B2 to assess baseline in vivo platelet activation and Thromboxane A2 (TxA2) bio-synthesis respectively. This assay measures the levels of chemicals in the blood that are released when a platelet is activated and reflects the extent of platelet activation in the circulation. 4. Adhesion and aggregation parameters obtained from platelet flow chamber assay. If appropriate consent is given by the TEMPLATE study participants, these test results may be used with data from other independent platelet testing studies for a wider diagnostic accuracy evaluation of the flow chamber methodology. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
These tests will be performed on all participants at each study visit.
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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 | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
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 | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.5 | The trial involves multiple Member States | No |
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 | No |
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
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The trial will end for a patient after they have completed the third study visit, 8 weeks after enrolment. The end of the trial is after all trial participants have completed study visit 3 and all bloods have been analysed and data queries resolved, the database locked and the analysis completed. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 1 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 10 |
E.8.9.2 | In all countries concerned by the trial days | 1 |