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ASCEND: A Study of Cardiovascular Events iN Diabetes

StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Publications: 12 to 14v15
  2. Collaborators: 6 to 9
    • Publications: 10 to 12
    v14
  3. Publications: 9 to 10v13
  4. Study description expanded, about 148 words
    • Study site revised
    • Collaborators: 4 to 6
    v12
  5. Re-verified, no change to tracked fieldsv11
Show 9 earlier versionsHide 9 earlier versions
  1. Results first posted: Apr 26, 2019
    • Primary endpoints revised (2)
    • Interventions: Omega-3-acid Ethyl Esters (Drug), Placebo Aspirin (Drug), Placebo omega-3-Ethyl Esters (Drug), aspirin (Drug) to Aspirin (Drug), Omega-3 Ethyl Esters (Drug), Placebo Aspirin (Drug), Placebo Omega-3 Ethyl Esters (Drug)
    • Secondary endpoints revised (2)
    v10
  2. Primary endpoints: 1 to 2v9 Show 4 more changesShow less
    • Primary completion date changed from estimate of Sep 2017 to Mar 12, 2018
    • Study completion date: Jul 31, 2037
    • Secondary endpoints revised (2)
    • Collaborators: 3 to 4
  3. Primary completion date: Dec 2016 to Sep 2017v8
  4. Primary endpoint revisedv7
  5. Enrollment target: estimated 15000 to confirmed 15480
    • Interventions: Omega-3-acid Ethyl Esters (Drug), aspirin (Drug) to Omega-3-acid Ethyl Esters (Drug), Placebo Aspirin (Drug), Placebo omega-3-Ethyl Esters (Drug), aspirin (Drug)
    • Study arms: 0 to 4
    v6
  6. Enrollment target: 10000 to 15000v5 Show 5 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Dec 2016
    • Secondary endpoints: details revised at 2 of 2 entries
    • Site details revised
    • Collaborators revised (3)
  7. 2 versions Re-verified since Mar 6, 2006, no change to tracked fieldsv3-v4
  8. Secondary endpoints revised (2)
    • Primary endpoint revised
    • Eligibility criteria expanded, about 2 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
University of Oxford
180 trials monitored
See 6 trials at risk
Diabetes
5,087 trials monitored
See 222 trials at risk
Type 2 Diabetes
2,231 trials monitored
See 111 trials at risk
Type 1 Diabetes
886 trials monitored
See 40 trials at risk
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.
Trial Details
NCT Number NCT00135226
Lead Sponsor University of Oxford
Collaborators: British Heart Foundation, Bayer, Medical Research Council, Solvay Pharmaceuticals, Abbott, Mylan, Health Data Research UK, Alzheimer's Research UK, The Macular Society
Conditions
(from sponsor)		 Diabetes Mellitus
Related terms Cardiovascular Diseases, Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Enrollment 15,480 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov