#263: Adaptable cohort query design and administration
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Reporter: schandaka | Owner: schandaka
Type: design-issue | Status: assigned
Priority: major | Milestone: adaptable-accrual
Component: data-stds | Resolution:
Keywords: | Blocked By: 444
Blocking: 353 |
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Comment (by lswander):
As a reminder to sites, we have added two additional exclusion criteria to
what is found in the final ADAPTABLE protocol (see #'s 9 and 10).
Here is the complete list:
Inclusion 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
a. No history of significant allergy to aspirin such as anaphylaxis,
urticaria, or significant gastrointestinal intolerances
b. No history of significant GI bleed within the past 12 months
c. No significant bleeding disorders that preclude the use of aspirin
4. Access to the Internet.
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
existing indications such as atrial fibrillation, deep venous thrombosis,
or pulmonary embolism.
6. Not currently treated with ticagrelor and not planned to be treated in
the future with ticagrelor.
7. Female patients who are not pregnant or nursing an infant
8. 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
Exclusion Criteria:
9. Exclude those not currently taking aspirin
10. Exclude those on Prasugrel (Effient)
Note: 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.
--
Ticket URL:
<http://informatics.gpcnetwork.org/trac/Project/ticket/263#comment:28>
gpc-informatics <http://informatics.gpcnetwork.org/>
Greater Plains Network - Informatics
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