Clinical Trials List
2014-02-01 - 2019-01-25
Phase III
Recruiting1
Terminated24
ICD-10E11.9
Type 2 diabetes mellitus without complications
ICD-10E13.9
Other specified diabetes mellitus without complications
ICD-9250.00
Diabetes mellitus without mention of complication, Type II [non-insulin dependent type][NIDDM type] [ adult-onset type] or unspecified type, not stated as uncontrolled
A Multinational, Randomised, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Ticagrelor Twice Daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Stroke in Patients With Type 2 Diabetes Mellitus (THEMIS - Effect of Ticagrelor on Health Outcomes in Diabetes Mellitus Patients Intervention Study).
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Trial Applicant
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Sponsor
AstraZeneca AB
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 林幸榮 醫學研究部
- Shih-Hsien Sung Division of Cardiovascular Diseases
- 林怡君 Division of Endocrinology
- Tse-Min Lu Division of Cardiovascular Diseases
- 黃少嵩 Division of Family Medicine
- Chin-Sung Kuo Division of Endocrinology
- 邱淳志 Division of Cardiovascular Diseases
- Wen-Chung Yu Division of Cardiovascular Diseases
- Kang-Ling Wang 新藥臨床試驗中心
- 吳承學 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Wen Lieng LEE Division of Endocrinology
- JUN-SING WANG Division of Endocrinology
- 潘泓智 Division of Cardiovascular Diseases
- I-TE LEE Division of Endocrinology
- 陳柏勳 Division of Endocrinology
- 傅家保 Division of Endocrinology
- 梁凱偉 Division of Cardiovascular Diseases
- 林時逸 Division of Endocrinology
- 李佳霖 Division of Endocrinology
- 郭怡婷 Division of Endocrinology
- 陳冠儒 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Ye-Hsu Lu Division of Cardiovascular Diseases
- Chun-Yuan Chu Division of Cardiovascular Diseases
- 溫文才 Division of Cardiovascular Diseases
- 朱志生 Division of Cardiovascular Diseases
- Cheng-An Chiu Division of Cardiovascular Diseases
- 顏學偉 Division of Cardiovascular Diseases
- 鄭凱鴻 Division of Cardiovascular Diseases
- Tsung-Hsien Lin Division of Cardiovascular Diseases
- Po-Chao Hsu Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 邱昱偉 Division of Cardiovascular Diseases
- 杜宗明 Division of Cardiovascular Diseases
- 黃姍惠 Division of Cardiovascular Diseases
- 許榮城 Division of Cardiovascular Diseases
- 陳運淇 Division of Cardiovascular Diseases
- 張藝耀 Division of Cardiovascular Diseases
- 劉芫宏 Division of Cardiovascular Diseases
- 莊文博 Division of Cardiovascular Diseases
- 林恆旭 Division of Cardiovascular Diseases
- 廖本智 Division of Cardiovascular Diseases
- 林俊忠 Division of Cardiovascular Diseases
- 柯欣榮 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 張懷仁 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Shih-Sheng Chang Division of Cardiovascular Diseases
- 林晏年 Division of Cardiovascular Diseases
- 盧炯睿 Division of Cardiovascular Diseases
- 陳科維 Division of Cardiovascular Diseases
- 王宇澄 Division of Cardiovascular Diseases
- Po-Yen Ko Division of Cardiovascular Diseases
- Lien-Cheng Hsiao Division of Cardiovascular Diseases
- 吳宏彬 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 黃鴻儒 Division of Cardiovascular Diseases
- 鄭錦昌 Division of Cardiovascular Diseases
- 賴奇正 Division of Cardiovascular Diseases
- 王玟樺 Division of Cardiovascular Diseases
- 蕭相江 Division of Cardiovascular Diseases
- 郭風裕 Division of Cardiovascular Diseases
- 黃偉春 Division of Cardiovascular Diseases
- 江承鴻 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 洪大川 Division of Cardiovascular Diseases
- 劉俊傑 Division of Cardiovascular Diseases
- 簡禎彥 Division of Cardiovascular Diseases
- 蘇正煌 Division of Cardiovascular Diseases
- 李應湘 Division of Cardiovascular Diseases
- 吳懿哲 Division of Cardiovascular Diseases
- 李俊偉 Division of Cardiovascular Diseases
- 郭任遠 Division of Cardiovascular Diseases
- 陳俊延 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Juey-Jen Hwang Division of Cardiovascular Diseases
- CHIA-TI TSAI Division of Cardiovascular Diseases
- 林俊立 Division of Cardiovascular Diseases
- JEN-KUANG LEE Division of Cardiovascular Diseases
- Tzung-Dau Wang Division of Cardiovascular Diseases
- 江福田 Division of Cardiovascular Diseases
- LIAN-YU LIN Division of Cardiovascular Diseases
- 洪啟盛 Division of Cardiovascular Diseases
- CHO-KAI WU Division of Cardiovascular Diseases
- YEN-HUNG LIN Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 李文煌 Division of Cardiovascular Diseases
- Po-Sheng Chen Division of Cardiovascular Diseases
- Wei-Chuan Tsai Division of Cardiovascular Diseases
- 李威廷 Division of Cardiovascular Diseases
- 林志展 Division of Cardiovascular Diseases
- Ting-Hsing Chao Division of Cardiovascular Diseases
- Cheng-Han Lee Division of Cardiovascular Diseases
- Chih-Hsin Hsu Division of Cardiovascular Diseases
- Ping-Yen Liu Division of Cardiovascular Diseases
- 李貽恆 Division of Cardiovascular Diseases
- Po-Tseng Lee Division of Cardiovascular Diseases
- Ju-Yi Chen Division of Cardiovascular Diseases
- Yen-Wen Liu Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 張容容 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Composite of Cardiovascular (CV) Death, MI or Stroke [ Time Frame: From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months. ]
Participants with Cardiovascular (CV) death, myocardial infarction (MI) or stroke. If no event, censoring occurs at the earliest of PACD, last endpoint assessment date and non-CV death date.
Secondary Outcome Measures :
CV Death [ Time Frame: From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months. ]
Participants with Cardiovascular (CV) death. If no event, censoring occurs at the earliest of PACD, last endpoint assessment date and non-CV death date.
MI [ Time Frame: From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months. ]
Participants with myocardial infarction. If no event, censoring occurs at the earliest of primary analysis censoring date (PACD), last endpoint assessment date and death date
Ischaemic Stroke [ Time Frame: From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months. ]
Participants with ischaemic stroke. If no event, censoring occurs at the earliest of PACD, last endpoint assessment date and death date.
All-cause Death [ Time Frame: From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months. ]
Participants with all-cause death. If no event, censoring occurs at the earliest of PACD and last endpoint assessment date. Includes deaths based on publically available vital status data in patients who have withdrawn consent.
Other Outcome Measures:
TIMI Major Bleeding Event (Primary Safety Objective) [ Time Frame: From randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months. ]
Participants with TIMI major bleeding event. If no event, censoring occurs at the earliest of last endpoint assessment date, death date and 7 days following the date of last dose of study medication
TIMI Major or Minor Bleeding Event [ Time Frame: From randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months. ]
Participants with TIMI major or minor bleeding event. If no event, censoring occurs at the earliest of last endpoint assessment date, death date and 7 days following the date of last dose of study medication
PLATO Major Bleeding Event [ Time Frame: From randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months. ]
Participants with PLATO major bleeding event. If no event, censoring occurs at the earliest of last endpoint assessment date, death date and 7 days following the date of last dose of study medication
Permanent Discontinuation of Study Medication Due to Any Bleeding Event [ Time Frame: From randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months. ]
Participants with permanent discontinuation of study medication due to any bleeding event. If no event, censoring occurs at the earliest of last endpoint assessment date, death date and the date of last dose of study medication
Inclution Criteria
Men or women ≥50 years of age with type 2 diabetes mellitus on treatment with a glucose lowering medication since at least 6 months, and either documented coronary artery occlusive disease or previous revascularization of a coronary artery.
Exclusion Criteria
History of myocardial infarction or any stroke; planned treatment with agents inhibiting blood clotting; planned use of ASA/Aspirin at doses above 150 mg daily; planned coronary, cerebrovascular, or peripheral arterial revascularization; patients with known bleeding disorders and patients who need chronic oral anticoagulant therapy or chronic low-molecular-weight heparin; history of intracranial bleeding at any time, or a history of bleeding from the gastrointestinal tract within the last 6 months or a major surgery within the last 30 days; patients with known severe liver disease or with kidney failure requiring dialysis
The Estimated Number of Participants
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Taiwan
806 participants
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Global
19000 participants
