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Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term (ADAPTABLE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02697916
Recruitment Status : Completed
First Posted : March 3, 2016
Results First Posted : July 1, 2021
Last Update Posted : July 1, 2021
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
Mytrus
Chicago Area Patient-Centered Outcomes Research Network (CAPriCORN)
Greater Plains Collaborative Clinical Data Research Network
Mid-South Clinical Data Research Network
Research Action for Health Network (REACHnet)
Patient-Centered Scalable National Network for Effectiveness Research
PaTH Clinical Data Research Network
New York City Clinical Data Research Network
Health eHeart Patient Powered Network
OneFlorida Clinical Data Research Network
HealthCore-Anthem Research Network
Humana-HUMnet
The Patient-Centered Network of Learning Health Systems
Information provided by (Responsible Party):
Duke University

Study Description
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Brief Summary:
ADAPTABLE is a pragmatic clinical trial in which 15,000 patients who are at high risk for ischemic events will be randomly assigned in a 1:1 ratio to receive an aspirin dose of 81 mg/day vs. 325 mg/day. Study participants will be enrolled over 38 months. Maximum follow-up will be 50 months. The purpose of the study is to identify the optimal dose of aspirin for secondary prevention in patients with Atherosclerotic cardiovascular disease (ASCVD). The primary endpoint is a composite of all-cause death, hospitalization for MI, or hospitalization for stroke. The primary safety endpoint is hospitalization for major bleeding with an associated blood product transfusion.

Condition or disease Intervention/treatment Phase
Atherosclerotic Cardiovascular Disease Drug: aspirin Not Applicable

Detailed Description:
In this pragmatic, patient-centered clinical trial, the investigators will compare the effectiveness of two doses of aspirin (81 mg and 325 mg) currently in widespread use in the United States in the secondary-prevention population of patients with established ASCVD. The trial will use a novel format that uses existing electronic health records (EHRs), as well as a web-based patient portal to collect patient-reported outcomes (PROs), and available patient encounter data to supplement/support the EHR. Patients who are identified as candidates for the trial will be directed to the electronic patient portal for the eConsent as well as an abbreviated eligibility confirmation and randomization. One of the important aims of ADAPTABLE is to engage patients, their healthcare providers, and trial investigators in using the infrastructure PCORnet has developed and continues to refine. A total of 15,000 high-risk patients with ASCVD will be randomly assigned (in an open-label fashion) in a 1:1 ratio to instructions to use a daily aspirin dose of either 81 mg or 325 mg daily. The investigators expect the entire sample of patients will be enrolled over 38 months, with a maximum follow-up of 50 months.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15076 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness
Actual Study Start Date : April 2016
Actual Primary Completion Date : June 30, 2020
Actual Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis
Drug Information available for: Aspirin

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: ASA 81mg
aspirin 81mg
 Drug: aspirin
81mg of aspirin daily vs. 325mg of aspirin daily
Other Name: ASA
Active Comparator: ASA 325mg
aspirin 325mg
 Drug: aspirin
81mg of aspirin daily vs. 325mg of aspirin daily
Other Name: ASA


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants Experiencing All-cause Death, Hospitalization for Nonfatal MI, or Hospitalization for Nonfatal Stroke in High-risk Patients With a History of MI or Documented Atherosclerotic Cardiovascular Disease (ASCVD) [ Time Frame: Time of randomization through study completion, approximately 4 years ]

Secondary Outcome Measures :
  1. Number of Participants Experiencing All-cause Death [ Time Frame: Time of randomization through study completion, approximately 4 years ]
  2. Number of Participants Experiencing Hospitalization for Nonfatal MI [ Time Frame: Time of randomization through study completion, approximately 4 years ]
  3. Number of Participants Experiencing Hospitalization for Nonfatal Stroke [ Time Frame: Time of randomization through study completion, approximately 4 years ]
  4. Number of Participants Requiring Coronary Revascularization Procedures (Percutaneous Coronary Intervention [PCI] or Coronary Artery Bypass Grafting [CABG]) [ Time Frame: Time of randomization through study completion, approximately 4 years ]
  5. Quality of Life and Functional Status, as Measured on a 5-point Scale [ Time Frame: 2 years ]
    Quality of life measures are based on an ordinal scale from 1-5, where 1 corresponds to the best outcome and 5 to the worst. Model-based mean score estimates are obtained from mixed models of each quality of life measure.


Other Outcome Measures:
  1. Number of Participants Experiencing Hospitalization for Major Bleeding Complications With an Associated Blood Product Transfusion [ Time Frame: Time of randomization through study completion, approximately 4 years ]

Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Known atherosclerotic cardiovascular disease (ASCVD), defined by a history of prior myocardial infarction, prior coronary angiography showing ≥75% stenosis of at least one epicardial coronary vessel, or prior coronary revascularization procedures (either PCI or CABG), or history of chronic heart disease, CAD, ASCVD
  • Age ≥ 18 years
  • No known safety concerns or side effects considered to be related to aspirin, including
  • No history of significant allergy to aspirin such as anaphylaxis, urticaria, or significant gastrointestinal intolerances
  • No history of significant GI bleed within the past 12 months
  • Significant bleeding disorders that preclude the use of aspirin
  • Access to the Internet. In the event that the CDRNs are notified that a cohort of patients without internet access can be included, then patient agreement will be obtained during the consent process to provide follow-up information by telephone contact with the DCRI Call Center.
  • Not currently treated with an oral anticoagulant - either warfarin or a novel anticoagulant (dabigatran, rivaroxaban, apixaban, edoxaban) - and not planned to be treated in the future with an oral anticoagulant for existing indications such as atrial fibrillation, deep venous thrombosis, or pulmonary embolism.
  • Not currently treated with ticagrelor and not planned to be treated in the future with ticagrelor.
  • Female patients who are not pregnant or nursing an infant
  • Estimated risk of a major cardiovascular event (MACE) > 8% over next 3 years as defined by the presence of at least one or more of the following enrichment factors:
  • Age > 65 years
  • Serum creatinine > 1.5 mg/dL
  • Diabetes mellitus (Type 1 or Type 2)
  • 3-vessel coronary artery disease
  • Cerebrovascular disease and/or peripheral arterial disease
  • Left ventricular ejection fraction (LVEF) < 50%
  • Current cigarette smoker
  • Chronic systolic or diastolic heart failure
  • SBP > 140 (within past 12 mos)
  • LDL > 130 (within past 12 mos)

Exclusion Criteria:

  • There will be no exclusions for any upper age limit, comorbid conditions, or concomitant medications other than oral anticoagulants and ticagrelor that are used at the time of randomization, or are planned to be used during the study follow-up.
  • Patients and sites interested in participating must be part of the listed health systems collaborators.
Contacts and Locations
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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): NCT02697916


Locations
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Sponsors and Collaborators
Duke University
Patient-Centered Outcomes Research Institute
Mytrus
Chicago Area Patient-Centered Outcomes Research Network (CAPriCORN)
Greater Plains Collaborative Clinical Data Research Network
Mid-South Clinical Data Research Network
Research Action for Health Network (REACHnet)
Patient-Centered Scalable National Network for Effectiveness Research
PaTH Clinical Data Research Network
New York City Clinical Data Research Network
Health eHeart Patient Powered Network
OneFlorida Clinical Data Research Network
HealthCore-Anthem Research Network
Humana-HUMnet
The Patient-Centered Network of Learning Health Systems
Investigators
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Principal Investigator: William S. Jones, MD Duke Clinical Research Institute
Principal Investigator: Adrian F. Hernandez, MD MHS FAHA Duke Clinical Research Institute
  Study Documents (Full-Text)

Documents provided by Duke University:
Study Protocol  [PDF] February 12, 2020
Statistical Analysis Plan  [PDF] February 9, 2021

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Jones WS, Mulder H, Wruck LM, Pencina MJ, Kripalani S, Munoz D, Crenshaw DL, Effron MB, Re RN, Gupta K, Anderson RD, Pepine CJ, Handberg EM, Manning BR, Jain SK, Girotra S, Riley D, DeWalt DA, Whittle J, Goldberg YH, Roger VL, Hess R, Benziger CP, Farrehi P, Zhou L, Ford DE, Haynes K, VanWormer JJ, Knowlton KU, Kraschnewski JL, Polonsky TS, Fintel DJ, Ahmad FS, McClay JC, Campbell JR, Bell DS, Fonarow GC, Bradley SM, Paranjape A, Roe MT, Robertson HR, Curtis LH, Sharlow AG, Berdan LG, Hammill BG, Harris DF, Qualls LG, Marquis-Gravel G, Modrow MF, Marcus GM, Carton TW, Nauman E, Waitman LR, Kho AN, Shenkman EA, McTigue KM, Kaushal R, Masoudi FA, Antman EM, Davidson DR, Edgley K, Merritt JG, Brown LS, Zemon DN, McCormick TE 3rd, Alikhaani JD, Gregoire KC, Rothman RL, Harrington RA, Hernandez AF; ADAPTABLE Team. Comparative Effectiveness of Aspirin Dosing in Cardiovascular Disease. N Engl J Med. 2021 May 27;384(21):1981-1990. doi: 10.1056/NEJMoa2102137. Epub 2021 May 15.

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02697916    
Other Study ID Numbers: Pro00068525
First Posted: March 3, 2016    Key Record Dates
Results First Posted: July 1, 2021
Last Update Posted: July 1, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Keywords provided by Duke University:
aspirin
ACSD
PCORI
Additional relevant MeSH terms:
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Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular 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