A Phase 3 interventional study of Ticagrelor 60 mg and Ticagrelor placebo in Diabetes Mellitus, Type 2, sponsored by AstraZeneca. Completed at 1,242 sites in 43 countries. Open to participants aged 50 Years to 130 Years. Per ClinicalTrials.gov, last updated 2020-03-18.
Sponsored by AstraZeneca · Phase 3, Interventional, and Prevention
The purpose of this study is to compare the effect of ticagrelor versus placebo in patients with Type 2 Diabetes Mellitus.
A multinational, randomised, double-blind, placebo-controlled phase IIIb 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
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 19,271 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion 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.
Key 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
Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.
Drug: Ticagrelor 60 mg
Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.
Drug: Ticagrelor placebo
Ticagrelor 60 mg bd taken orally as tablets
Also known as: Brilinta/Brilique
Ticagrelor placebo bd taken orally as tablets
Composite of Cardiovascular (CV) Death, MI or Stroke
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.
Time frame: From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.
CV Death
Participants with Cardiovascular (CV) death. If no event, censoring occurs at the earliest of PACD, last endpoint assessment date and non-CV death date.
Time frame: From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.
MI
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
Time frame: From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.
Ischaemic Stroke
Participants with ischaemic stroke. If no event, censoring occurs at the earliest of PACD, last endpoint assessment date and death date.
Time frame: From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.
All-cause Death
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.
Time frame: From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.
TIMI Major Bleeding Event (Primary Safety Objective)
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
Time frame: From randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.
TIMI Major or Minor Bleeding Event
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
Time frame: From randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.
PLATO Major Bleeding Event
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
Time frame: From randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.
Permanent Discontinuation of Study Medication Due to Any Bleeding Event
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
Time frame: From randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.
1315 study sites in 42 countries enrolled patients. The first patient was enrolled on 10 February 2014. The last patient visit took place on 25 January 2019.
| Milestone | Ticagrelor 60 mg | Ticagrelor Placebo |
|---|---|---|
| Started | 9645 | 9626 |
| Completed | 9496 | 9503 |
| Not completed | 149 | 123 |
| Withdrew: Lost to follow-up | 6 | 4 |
| Withdrew: Withdrawal by subject | 117 | 94 |
| Withdrew: Site prematurely closed by sponsor | 26 | 25 |
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.
| Number of participants with event | Ticagrelor 60 mg | Ticagrelor Placebo |
|---|---|---|
| Composite of Cardiovascular (CV) Death, MI or Stroke | 736 | 818 |
Participants with Cardiovascular (CV) death. If no event, censoring occurs at the earliest of PACD, last endpoint assessment date and non-CV death date.
| Number of participants with event | Ticagrelor 60 mg | Ticagrelor Placebo |
|---|---|---|
| CV Death | 364 | 357 |
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
| Number of participants with event | Ticagrelor 60 mg | Ticagrelor Placebo |
|---|---|---|
| MI | 274 | 328 |
Participants with ischaemic stroke. If no event, censoring occurs at the earliest of PACD, last endpoint assessment date and death date.
| Number of participants with event | Ticagrelor 60 mg | Ticagrelor Placebo |
|---|---|---|
| Ischaemic Stroke | 152 | 191 |
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.
| Number of participants with event | Ticagrelor 60 mg | Ticagrelor Placebo |
|---|---|---|
| All-cause Death | 579 | 592 |
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
| Number of participants with event | Ticagrelor 60 mg | Ticagrelor Placebo |
|---|---|---|
| TIMI Major Bleeding Event (Primary Safety Objective) | 206 | 100 |
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
| Number of participants with event | Ticagrelor 60 mg | Ticagrelor Placebo |
|---|---|---|
| TIMI Major or Minor Bleeding Event | 285 | 129 |
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
| Number of participants with event | Ticagrelor 60 mg | Ticagrelor Placebo |
|---|---|---|
| PLATO Major Bleeding Event | 310 | 145 |
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
| Number of participants with event | Ticagrelor 60 mg | Ticagrelor Placebo |
|---|---|---|
| Permanent Discontinuation of Study Medication Due to Any Bleeding Event | 466 | 125 |
Collected over All-cause death includes all deaths that occur between randomisation and last visit (before and after primary analysis censoring date, and including vital status known from public records). The other adverse event categories are presented with event onset date between randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ticagrelor 60 mg | 589/9,619 (6.1%) | 3,049/9,562 (31.9%) | 1,951/9,562 (20.4%) |
| Ticagrelor Placebo | 602/9,601 (6.3%) | 3,210/9,531 (33.7%) | 610/9,531 (6.4%) |
| Event | Ticagrelor 60 mg | Ticagrelor Placebo |
|---|---|---|
| Angina unstableCardiac disorders | 354/9562 | 405/9531 |
| Angina pectorisCardiac disorders | 200/9562 | 251/9531 |
| Acute myocardial infarctionCardiac disorders | 126/9562 | 197/9531 |
| PneumoniaInfections and infestations | 130/9562 | 147/9531 |
| Ischaemic strokeNervous system disorders | 85/9562 | 119/9531 |
| Coronary artery diseaseCardiac disorders | 85/9562 | 90/9531 |
| Cardiac failureCardiac disorders | 64/9562 | 87/9531 |
| Atrial fibrillationCardiac disorders | 82/9562 | 76/9531 |
| Non-cardiac chest painGeneral disorders | 54/9562 | 66/9531 |
| Myocardial infarctionCardiac disorders | 41/9562 | 65/9531 |
| Event | Ticagrelor 60 mg | Ticagrelor Placebo |
|---|---|---|
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 1951/9562 | 610/9531 |
Of the 19271 patients randomised to study drug, 51 patients were randomised to study drug at a site prematurely closed by sponsor and excluded from the study results. 19220 were included in the evaluation of study results.
| Age, Continuous(Years) | Ticagrelor 60 mg | Ticagrelor Placebo | Total |
|---|---|---|---|
| Mean | 66.3 ± 7.8 | 66.3 ± 7.7 | 66.3 ± 7.8 |
| Sex: Female, Male(Participants) | Ticagrelor 60 mg | Ticagrelor Placebo | Total |
|---|---|---|---|
| Female | 3043 | 2988 | 6031 |
| Male | 6576 | 6613 | 13189 |
| Race/Ethnicity, Customized(Participants) | Ticagrelor 60 mg | Ticagrelor Placebo | Total |
|---|---|---|---|
| White | 6838 | 6858 | 13696 |
| Black or african american | 205 | 198 | 403 |
| Asian | 2211 | 2195 | 4406 |
| Native hawaiian or other pacific islander | 7 | 7 | 14 |
| American indian or alaska native | 161 | 152 | 313 |
| Other | 197 | 191 | 388 |
| Region of Enrollment(Participants) | Ticagrelor 60 mg | Ticagrelor Placebo | Total |
|---|---|---|---|
| USA | 1126 | 1140 | 2266 |
| Argentina | 195 | 199 | 394 |
| Australia | 94 | 94 | 188 |
| Austria | 42 | 45 | 87 |
| Belgium | 109 | 108 | 217 |
| Bulgaria | 435 | 443 | 878 |
| Brazil | 412 | 399 | 811 |
| Canada | 364 | 365 | 729 |
| Chile | 152 | 148 | 300 |
| China | 456 | 454 | 910 |
| Colombia | 68 | 68 | 136 |
| Czech Republic | 304 | 298 | 602 |
| Germany | 277 | 270 | 547 |
| Denmark | 123 | 120 | 243 |
| Spain | 170 | 170 | 340 |
| Finland | 60 | 58 | 118 |
| France | 85 | 87 | 172 |
| United Kingdom | 123 | 123 | 246 |
| Hong Kong | 76 | 76 | 152 |
| Hungary | 306 | 310 | 616 |
| India | 147 | 145 | 292 |
| Israel | 60 | 57 | 117 |
| Italy | 67 | 63 | 130 |
| Japan | 246 | 250 | 496 |
| Korea, Republic Of | 433 | 437 | 870 |
| Mexico | 182 | 182 | 364 |
| Netherlands | 242 | 237 | 479 |
| Norway | 95 | 96 | 191 |
| Peru | 91 | 82 | 173 |
| Philippines | 47 | 45 | 92 |
| Poland | 815 | 821 | 1636 |
| Romania | 37 | 43 | 80 |
| Russia | 561 | 560 | 1121 |
| Saudi Arabia | 79 | 76 | 155 |
| Slovakia | 122 | 122 | 244 |
| Sweden | 110 | 114 | 224 |
| Thailand | 115 | 116 | 231 |
| Turkey | 113 | 112 | 225 |
| Taiwan, Province Of China | 402 | 401 | 803 |
| Ukraine | 399 | 393 | 792 |
| Viet Nam | 129 | 125 | 254 |
| South Africa | 150 | 149 | 299 |
Showing the first 100 of 1,242 sites across 43 countries.
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