#263: Adaptable cohort query design and administration
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Reporter: nateapathy | Owner: rwaitman
Type: design-issue | Status: new
Priority: minor | Milestone: adaptable-accrual
Component: data-stds | Resolution:
Keywords: | Blocked By: 276
Blocking: |
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Changes (by bzschoche):
* cc: schandaka (added)
Comment:
From the ADAPTABLE protocol draft released Aug 12, 2015, pp. 20-21. (see
attachment:"ADAPTABLE Protocol_081215.docx")
Inclusion / Exclusion criteria:
1. 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)
2. Age ≥ 18 years
3. 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 recent upper gastrointestinal events including a
symptomatic gastric or duodenal ulcer or an upper gastrointestinal
bleeding event within the past 12 months
- Significant bleeding disorders that preclude the use of aspirin
4. Access to the Internet or agreement to collect follow-up information by
the DCRI Call Center from patients without Internet access
5. 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
indications such as atrial fibrillation, deep venous thrombosis, or
pulmonary embolism.
6. Female patients who are not pregnant or nursing an infant
7. 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
- Known serum creatinine > 1.5 mg/dL
- Diabetes mellitus
- Known 3-vessel coronary artery disease
- Known cerebrovascular disease and/or peripheral arterial disease
- Known left ventricular ejection fraction (LVEF) < 50%
- Current cigarette smoker.
8. Able and willing to provide informed consent and agreeing to be
followed through the Internet and/or through calls by the DCRI Call Center
for the duration of the trial (maximum expected follow-up of 30 months)
There will be no exclusions for any upper age limit, comorbid conditions,
or concomitant medications other than oral anticoagulants that are used at
the time of randomization or are planned to be used during the study
follow-up.
--
Ticket URL:
<http://informatics.gpcnetwork.org/trac/Project/ticket/263#comment:11>
gpc-informatics <http://informatics.gpcnetwork.org/>
Greater Plains Network - Informatics
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