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ASCEND: A Study of Cardiovascular Events iN Diabetes

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ClinicalTrials.gov Identifier: NCT00135226
Recruitment Status : Active, not recruiting
First Posted : August 25, 2005
Last Update Posted : August 21, 2018
Sponsor:
Collaborators:
British Heart Foundation
Bayer
EPD Research Ltd.
Medical Research Council
Information provided by (Responsible Party):
University of Oxford

Brief Summary:
The purpose of this study is to determine whether 100mg daily aspirin versus placebo and/or supplementation with 1 gram daily omega-3 fatty acids or placebo prevents "serious vascular events" (i.e. non-fatal heart attack, non-fatal stroke or transient ischaemic attack, or death from vascular causes) in patients with diabetes who are not known to have occlusive arterial disease and to assess the effects on serious bleeding or other adverse events.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: aspirin Drug: Omega-3-acid Ethyl Esters Drug: Placebo Aspirin Drug: Placebo omega-3-Ethyl Esters Phase 4

Detailed Description:

The role of antiplatelet therapy (chiefly aspirin) for the secondary prevention of heart attacks and strokes is firmly established for many high-risk people with diagnosed arterial disease, and the proportional reductions in these cardiovascular events appear to be about one quarter, whether or not such patients have diabetes. But, most younger and middle-aged people with diabetes do not have manifest arterial disease - although they are still at significant cardiovascular risk - and yet few trials have tested aspirin in such individuals. As a result, there is substantial uncertainty about the role of aspirin for the prevention of heart attacks and strokes among apparently healthy people with diabetes, and only a small minority receives it.

There is consistent evidence from observational studies of lower rates of cardiovascular disease (particularly cardiac and sudden death) in people with higher intakes, or higher blood levels, of fish oils (omega-3 fatty acids). Trials in people who have survived a heart attack have shown modest, but potentially worthwhile, reductions in coronary events. There have been, however, no large-scale trials of the use of fish oils for the prevention of vascular events in people without diagnosed arterial disease.

If ASCEND can reliably demonstrate that aspirin and/or fish oils safely reduce the risk of cardiovascular events and deaths in people with diabetes who do not have pre-existing arterial disease, then this would be relevant to some tens of millions of people world-wide (who are currently not receiving such therapy) and might save tens of thousands of lives each year.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15480 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Study of Cardiovascular Events iN Diabetes - A Randomized 2x2 Factorial Study of Aspirin Versus Placebo, and of Omega-3 Fatty Acid Supplementation Versus Placebo, for Primary Prevention of Cardiovascular Events in People With Diabetes
Study Start Date : March 2005
Actual Primary Completion Date : March 12, 2018
Estimated Study Completion Date : July 31, 2037

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Aspirin + Omega-3-Ethyl Esters
Participants receive 100mg of aspirin once daily and 1g of omega-3-Ethyl Esters once daily.
Drug: aspirin
Drug: Omega-3-acid Ethyl Esters
Active Comparator: Aspirin + Placebo Omega-3-Ethyl Esters
Participants receive 100mg of aspirin once daily and placebo omega-3-Ethyl Esters once daily.
Drug: aspirin
Drug: Placebo omega-3-Ethyl Esters
Active Comparator: Placebo Aspirin + Omega-3-Ethyl Esters
Participants receive placebo aspirin once daily and 1 g of omega-3-Ethyl Esters once daily.
Drug: Omega-3-acid Ethyl Esters
Drug: Placebo Aspirin
Active Comparator: Placebo Aspirin + Placebo Omega-3-Ethyl Esters
Participants receive placebo aspirin once daily and placebo omega-3-Ethyl Esters once daily.
Drug: Placebo Aspirin
Drug: Placebo omega-3-Ethyl Esters



Primary Outcome Measures :
  1. For both the aspirin & omega-3 treatment arms: First occurrence of any Serious Vascular Event (SVE) [ Time Frame: Randomized treatment phase during a mean of 7.4 years ]

    The primary efficacy assessments will involve intention-to-treat comparisons among all randomized participants of assignment to aspirin versus placebo and, separately, of omega-3 fatty acids versus placebo on the first occurrence of any "Serious Vascular Event" (SVE), defined as:

    • non-fatal myocardial infarction; or
    • non-fatal stroke (excluding confirmed intracranial hemorrhage) or TIA; or
    • vascular death excluding confirmed intracranial hemorrhage (defined as International Classification of Diseases 10th revision [ICD-10] I00-52 or I63-99, i.e. excluding subarachnoid hemorrhage [I60], intracerebral hemorrhage [I61], and other non-traumatic intracranial hemorrhage [I62]).

  2. For the aspirin treatment arm only: first occurrence of any major bleed. [ Time Frame: Randomized treatment phase during a mean of 7.4 years ]

    The primary safety assessments will involve intention-to-treat comparisons among all randomized patients of assignment to aspirin versus placebo on the first occurrence of "any major bleed", defined as:

    • any confirmed intracranial hemorrhage (including intracerebral, subarachnoid, subdural or any other intracranial hemorrhage); or
    • sight-threatening eye bleeding; or
    • any other serious bleeding episode.


Secondary Outcome Measures :
  1. For both treatment arms: Combined end-point of Serious Vascular Events (SVEs) or revascularizations [ Time Frame: Randomized treatment phase during a mean of 7.4 years ]
    Secondary efficacy assessments of aspirin will involve intention-to-treat comparisons during the scheduled treatment period among all randomized participants on the first occurrence of the expanded vascular endpoint of "SVE or revascularization" (including coronary and non-coronary revascularizations).

  2. For the aspirin treatment arm only: any incident gastrointestinal (GI) tract cancer [ Time Frame: Randomized treatment phase during a mean of 7.4 years ]
    Any incident gastrointestinal (GI) tract cancer (i.e. any GI cancer excluding pancreas and hepatobiliary), overall and after exclusion of the first three years of follow-up.


Other Outcome Measures:
  1. Serious vascular event or revascularization in various prognostic subgroups and other exploratory outcomes defined in the Data Analysis Plan (https://www.ahjonline.com/article/S0002-8703(17)30392-7/addons) [ Time Frame: Randomized treatment phase during a mean of 7.4 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females with type 1 or type 2 diabetes mellitus.
  • Aged ≥ 40 years.
  • No previous history of vascular disease.
  • No clear contra-indication to aspirin.
  • No other predominant life-threatening medical problem.

Exclusion Criteria:

  • Definite history of myocardial infarction, stroke or arterial revascularisation procedure.
  • Currently prescribed aspirin, warfarin or any other blood thinning medication.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00135226


Locations
United Kingdom
Clinical Trial Service Unit, University of Oxford
Oxford, United Kingdom, OX3 7LF
Sponsors and Collaborators
University of Oxford
British Heart Foundation
Bayer
EPD Research Ltd.
Medical Research Council
Investigators
Principal Investigator: Jane M Armitage, BSc, MBBS, MRCP, FFPH Clinical Trial Service Unit, University of Oxford

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT00135226     History of Changes
Other Study ID Numbers: CTSUASCEND1
EUDRACT: 2004-000991-15
First Posted: August 25, 2005    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018

Keywords provided by University of Oxford:
Diabetes Mellitus
Cardiovascular Disease
Aspirin
Omega-3 fatty acids
Primary prevention
Randomized Controlled Trial
Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics