CABANA Inclusion Criteria #2 – Warrant active therapy beyond simple ongoing observation
The prior interpretation of this inclusion criterion had required that a patient treated with an AF drug
experience a recurrence or symptoms on that drug, thus necessitating either a change in dose or
change in drug.
The revised interpretation allows us to approach and enroll patients for randomization who have been
recently started on a new drug (within the past 3 months) without requiring that dose or drug be
1) If initiation of the drug is recent, it may not be known how the patient will respond to that
medication. Thus, allowing the recently started drug to be the first drug in the trial, if randomized to
2) If we maintain the requirement that there must be a change in therapy, patients on a recently
started drug could not be enrolled unless that drug had been shown to be ineffective or intolerant
prior to enrolment. Such patients would then have one less drug option for future use.
3) With fewer drugs failed and more drug choices left as options, there may be a decrease in
requests for crossover to ablation. Thus, improving the ability to keep patients in the medical arm
4) Rather than maintaining the strict interpretation that “requiring treatment” means “change in
treatment,” and requiring patients recently started on a drug must “fail” that drug before they are
eligible, this protocol clarification allows the trial to obtain information on patients that have recently
started drug therapy but not yet failed.