A Study Comparing Cardiovascular Effects of Ticagrelor Versus Placebo in Patients With Type 2 Diabetes Mellitus (THEMIS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01991795
First received: November 18, 2013
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to compare the effect of ticagrelor versus placebo in patients with Type 2 Diabetes Mellitus.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Ticagrelor 90 mg
Drug: Ticagrelor placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Multinational, Randomised, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Ticagrelor 90 mg 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)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Time from randomisation to first occurrence of any event from the composite of CV death, MI or stroke [ Time Frame: Up to 35 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time from randomisation to first occurrence of any event from the composite of all-cause death, MI or stroke [ Time Frame: Up to 35 months ] [ Designated as safety issue: No ]
  • Time from randomisation to death of CV cause [ Time Frame: Up to 35 months ] [ Designated as safety issue: No ]
  • Time from randomisation to death of any cause [ Time Frame: Up to 35 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 19000
Study Start Date: May 2013
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ticagrelor 90 mg Drug: Ticagrelor 90 mg
Ticagrelor 90 mg bd taken orally as tablets
Other Name: Brilinta/Brilique
Placebo Comparator: Ticagrelor placebo Drug: Ticagrelor placebo
Ticagrelor placebo bd taken orally as tablets

Detailed Description:

A multinational, randomised, double-blind, placebo-controlled phase IIIb trial to evaluate the effect of ticagrelor 90 mg twice daily on the incidence of cardiovascular death, myocardial infarction or stroke in patients with type 2 diabetes mellitus

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01991795

Contacts
Contact: Magnus Petersson, MD, PhD ClinicalTrialTransparency@astrazeneca.com

  Show 748 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Philippe Gabriel Steg, MD Hôpital Bichat-Claude Bernard 46 Rue Henri Huchard, Paris
Principal Investigator: Deepak L. Bhatt, MD Brigham and Women's Hospital75 Francis Street, Boston
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01991795     History of Changes
Other Study ID Numbers: D513BC00001
Study First Received: November 18, 2013
Last Updated: July 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Diabetes
Coronary artery disease
Outcome
Prevention
Antiplatelet

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Adenosine
Ticagrelor
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Vasodilator Agents
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014