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ASCEND: A Study of Cardiovascular Events iN Diabetes

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

Record History

  1. Publications: 12 to 14v15 Show moreShow less

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  2. Collaborators: 6 to 9 Publications: 10 to 12v14 Show all 2 changesShow less
    • Publications: 10 to 12

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  3. Publications: 9 to 10v13 Show moreShow less

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  4. Study description expanded, about 148 words Study site revised · Collaborators: 4 to 6v12 Show all 3 changesShow less
    • Study site revised
    • Collaborators: 4 to 6

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  5. Re-verified, no change to tracked fieldsv11
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  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 Show all 4 changesShow less
    • 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)

    See this version in full on ClinicalTrials.gov ↗

  2. Primary endpoints: 1 to 2 Primary completion date changed from estimate of Sep 2017 to Mar 12, 2018 · Completion date: Jul 31, 2037 · Secondary endpoints revised (2) · 1 morev9 Show all 5 changesShow less
    • Primary completion date changed from estimate of Sep 2017 to Mar 12, 2018
    • Completion date: Jul 31, 2037
    • Secondary endpoints revised (2)
    • Collaborators: 3 to 4

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  3. Primary completion date: Dec 2016 to Sep 2017v8
  4. Primary endpoint revisedv7 Show moreShow less

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  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 4v6 Show all 3 changesShow less
    • 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
  6. Enrollment target: 10000 to 15000 Trial status: Recruiting to Active, Not Recruiting · Primary completion date: Dec 2016 · Secondary endpoints: details revised at 2 of 2 entries · 2 morev5 Show all 6 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)

    See this version in full on ClinicalTrials.gov ↗

  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 wordsv2 Show all 3 changesShow less
    • Primary endpoint revised
    • Eligibility criteria expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  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
4,286 trials monitored
See 187 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 Diabetes Mellitus
Enrollment 15,480 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov