Ulcer Bleeding Clinical Trial
Official title:
Prevention of Recurrent Ulcer Bleeding in High-risk Aspirin Users Who Are Not Infected With Helicobacter Pylori: A Prospective Cohort Study (NSAID#3NANC Study)
Low-dose aspirin is the mainstay of treatment for patients with coronary heart disease and
stroke. However, low-dose aspirin increases the risk of ulcer bleeding. Current evidence
indicates that 80 - 100 mg of aspirin daily provides good protection against vascular events
and the risk of ulcer bleeding is low (about 1% per year). Since the overall risk of
bleeding is low, aspirin users who do not have previous ulcer disease do not require
prophylaxis with anti-ulcer drugs. In contrast, aspirin users with a history of ulcer
disease have a 2- to 4-fold increased risk of ulcer bleeding. The best strategy for reducing
the risk of bleeding in high-risk aspirin users remains unclear. Current strategies for
high-risk patients include the use of anti-ulcer drugs, elimination of risk factors (e.g.
Helicobacter pylori), or the use of enteric-coated aspirin.
Although co-therapy of aspirin with an acid suppressant reduces the risk of ulcer bleeding,
drug compliance may limit its clinical usefulness particularly in patients who are already
receiving multiple drugs. The efficacy of enteric-coated aspirin in preventing ulcer
complications showed conflicting results. One study found that enteric-coated aspirin
increases the risk of ulcer bleeding. A recent study showed that enteric-coated aspirin
causes minimal acute gastric injury.
The investigators postulated that among patients without H. pylori infection and a history
of ulcer bleeding who continue to use low-dose aspirin, enteric-coated aspirin reduces the
long-term risk of ulcer complications to a level that is comparable to that of average-risk
aspirin users.
Low-dose aspirin is increasingly used for the prophylaxis against coronary heart disease and
stroke. However, it is also an important cause of peptic ulcer bleeding worldwide. In
England and Wales, low-dose aspirin is estimated to account for about 10% of ulcer bleeding
in people aged 60 and over [Weil 1995]. The problem of aspirin-related ulcer disease is
expanding with the increasing use of aspirin for cardiovascular prophylaxis.
No dose of aspirin is entirely free of risk. Using a daily dose of aspirin as low as 75 mg,
the risk of ulcer bleeding doubles that of non-users [Weil 1995]. Previous ulcer disease and
concurrent major medical illnesses are important risk factors for ulcer bleeding with
low-dose aspirin. Among aspirin users, those with previous ulcer disease have a 5-fold
increased risk of ulcer bleeding [Lanas 2000].
Various strategies have been used to prevent recurrent ulcer bleeding in high-risk aspirin
users, such as eradication of Helicobacter pylori, the use of prophylactic anti-ulcer drugs
or enteric-coated aspirin. Recently, the investigators have shown that the eradication of H.
pylori is comparable to maintenance treatment with omeprazole, a potent acid suppressant, in
preventing recurrent ulcer bleeding for high-risk aspirin users [Chan 2001]. However, about
50% of aspirin users are not infected with H. pylori.
The optimal strategy to prevent ulcer complications for high-risk aspirin users who are not
infected with H. pylori remains undefined. Although co-therapy of aspirin with an acid
suppressant reduces the risk of ulcer bleeding, drug compliance may limit its clinical
usefulness particularly in patients who are already receiving multiple drugs.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03160911 -
The Use of Over-the-scope-clip for Prevention of Rebleeding in High Risk Peptic Ulcers
|
N/A | |
| Terminated |
NCT02352155 -
Second-look Endoscopy in High Risk Patients After Endoscopic Hemostasis to Their Bleeding Peptic Ulcers Improves Their Outcomes
|
N/A |