Evaluate Misoprostol for the Healing of Small Bowel Ulcers in Low-dose Aspirin Users Complicated by Small Bowel Bleeding
Status:
Completed
Trial end date:
2018-02-01
Target enrollment:
Participant gender:
Summary
ASA is the most commonly drug used worldwide for prevention of cardiovascular diseases.
However, ASA is increasingly recognized as a culprit for small bowel bleeding. Small bowel
bleeding is notoriously difficult to diagnose because it is beyond the reach of conventional
endoscopy. The advent of wireless, video capsule endoscopy has revolutionized the
visualization of small bowel. Capsule endoscopy is a pill that contains a tiny camera for
capturing pictures of the small bowel after being swallowed. Currently, capsule endoscopy is
a recommended noninvasive approach of identifying the source of small bowel bleeding.
Management of ASA-associated small bowel bleeding is a major clinical challenge since there
is not a single effective treatment for small bowel ulcer, and continuation of ASA increases
the risk of recurrent small bowel bleeding. However, discontinuation of ASA exposes patients
to thrombotic complications. Suppression of prostaglandin synthesis is an important mechanism
of ASA-induced small injury. Consistent with this theory, preliminary data from a case series
showed that misoprostol, a prostaglandin analog, healed small bowel ulcers in ASA users.
However, the efficacy of misoprostol in healing ASA-associated small bowel ulcers has not yet
been confirmed by prospective randomized trials.
This double-blind clinical trial tests the hypothesis that misoprostol can heal small bowel
ulcers in Aspirin users complicated by small bowel bleeding.