E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Myocardial Infarction, Cardiovascular Death, Atherothombosis, Stroke
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E.1.1.1 | Medical condition in easily understood language |
Heart Attack, Death from Heart Disease, Condition that leads to heart attack, and stroke
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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 | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10007648 |
E.1.2 | Term | Cardiovascular disease, unspecified |
E.1.2 | System Organ Class | 100000004849 |
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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 primary objective of the study is to see if a new drug called ticagrelor given twice daily in addition to the aspirin therapy decreases the frequency of cardiovascular events (e.g., death from heart or vascular disease, heart attack, or stroke) in patients with prior heart attack. |
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E.2.2 | Secondary objectives of the trial |
The first secondary objective of this study is to see if a new drug called ticagrelor given twice daily in addition to the aspirin therapy reduces the frequency of death from heart or vascular disease in patients with prior heart attack.
The second secondary objective of this study is to see if a new drug called ticagrelor given twice daily in addition to the aspirin therapy reduces the frequency of death in patients with prior heart attack.
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Title: Cardiovascular Biomarker Substudy
Date: 09 September 2010
Version: FINAL
Objecitves:
1. To evaluate the value of biomarkers for predicting ischemic/thrombotic and bleeding events.
2. To evaluate whether patients indentified at higher risk on the basis of biomarkers experience a greater absolute and/or relative risk reduction in ischemic/thrombotic events with long-term treatment with ticagrelor vs. placebo.
3. To evaluate the correlation between platelet inhibition and ischemic/thrombotic and bleeding outcomes.
4. To evaluate whether treatment with ticagrelor reduces levels of biomarkers of inflammation, platelet activation, thrombosis, and endothelial dysfunction.
Title: Pharmacogenetics Research Substudy
Date: 09 September 2010
Version: FINAL
Objecitves: The objective of this research, with appropriate informed consent, is to collect and store DNA for exploratory research into genes/genetic variation that may influence response (ie, distribution, safety, tolerability and efficacy) to ticagrelor and other cardiovascular medications and/or susceptibility to and/or prognosis of cardiovascular, metabolic and related diseases. |
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E.3 | Principal inclusion criteria |
Men and women ≥50 years of age.
Person who had a heart attack within 1 – 3 years ago and at least one additional risk factor: Age ≥ 65 years old, Diabetes requiring medication, Documented history of 2nd prior MI (>1 year ago). Angiographic evidence of multivessel CAD, and / or Chronic, non-end stage renal dysfunction.
Females of child-bearing potential must have a negative pregnancy test at enrollment and be willing to use medically accepted method of contraception.
Patient must be currently taking aspirin, with a planned maintenance dose between 75 and 150 mg once daily. |
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E.4 | Principal exclusion criteria |
Persons who are being treated with agents inhibiting blood clotting if the agent cannot be stopped at study start.
Persons who have planned coronary, cerebrovascular, or peripheral arterial revascularization (invasive surgery) at study start.
Persons with known bleeding disorders.
Persons who need chronic oral anticoagulant therapy or chronic low-molecular-weight heparin.
Persons with a history of ischemic stroke.
Persons with a history of intracranial bleeding at any time, a tumor or blood vessel abnormality in the brain and/or spinal cord at any time, a history of surgery involving the brain or spinal cord within the last 5 years, or a history of bleeding from the gastrointestinal tract (eg, esophagus, stomach, colon, rectum) within the last 6 months or a major surgery within the last 30 days.
Persons considered to be at risk of bradycardic events unless already treated with a permanent pacemaker.
Persons who have had open heart surgery within the past 5 years, unless the person had a heart attack after the surgery.
Persons with known severe liver disease.
Persons with kidney failure requiring dialysis.
Persons with life expectancy < 1 year. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Any event after randomization from the composite of cardiovascular death, non-fatal MI, or non-fatal stroke. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Within 1 year to 38 months |
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E.5.2 | Secondary end point(s) |
Cardiovascular death after randomization.
All-cause mortality after randomization. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Within 1 year to 38 months for both secondary endpoints |
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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 | Yes |
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 | 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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 30 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 400 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Argentina |
Australia |
Belgium |
Brazil |
Bulgaria |
Canada |
Chile |
China |
Colombia |
Czech Republic |
France |
Germany |
Hungary |
India |
Italy |
Japan |
Korea, Republic of |
Netherlands |
Norway |
Spain |
Sweden |
Peru |
Philippines |
Poland |
Romania |
Russian Federation |
Slovakia |
South Africa |
Turkey |
Ukraine |
United Kingdom |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
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 end of the entire study is defined as “the last visit of the last patient undergoing the trial”. |
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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 | |
E.8.9.1 | In the Member State concerned months | 38 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 38 |