When Should Low-dose Aspirin be Resumed After Peptic Ulcer Bleeding? A Randomized Controlled Trial
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|ClinicalTrials.gov Identifier: NCT03785015|
Recruitment Status : Not yet recruiting
First Posted : December 24, 2018
Last Update Posted : December 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Aspirin GastroIntestinal Bleeding||Other: Resume Aspirin within 12 hours Other: Resume Aspirin 72 - 84 hours||Not Applicable|
Acute upper gastrointestinal (GI) bleeding associated with the use of low-dose aspirin (ASA) is a major cause of peptic ulcer bleeding worldwide. Among survivors of acute myocardial infarction, a study of over 14,000 patients reported that the risk of life-threatening GI bleeding in the first two months is 7 times higher than that in the subsequent months (1). After endoscopic control of ulcer bleeding, most patients with cardiovascular (CV) diseases will need to resume ASA. Clinicians often face the dilemma: when should ASA be resumed? Furthermore, patients who suffer from acute peptic ulcer bleeding are often elderly patients with significant co-morbidities. Mortality in these patients remains high. Clinicians are facing an increasing number of patients who are on antiplatelet drugs or anticoagulants.
However, there are very limited data to guide the best timing for resumption of ASA in these high risk patients. To date, our group has conducted the only randomized controlled trial in the literature that has partially addressed this issue. Importantly, we found that immediate resumption of ASA saves life but at the expense of higher risk of recurrent bleeding (2). Accordingly, current international guidelines recommend early resumption of ASA but the optimal timing is unknown.
In the setting of acute GI bleeding, it is often a dilemma whether to stop or to restart these drugs. The balance between bleeding and thrombotic risks is difficult and treatment is often empirical and not evidence-based.
We aim to test the hypothesis that in ASA users complicated by peptic ulcer bleeding, withholding ASA till day 3 reduces the risk of recurrent bleeding compared to immediate resumption of ASA without a significant increase in mortality.
- Moukarbel GV, Signorovitch JE, Pfeffer MA et al. Gastrointestinal bleeding in high risk survivors of myocardial infarction: the VALIANT Trial. Eur Heart J 2009;30(18):2226-32.
- Sung JJ, Lau JY, Ching JY et al. Continuation of low-dose aspirin therapy in peptic ulcer bleeding: a randomized trial. Ann Intern Med 2010;152(1):1-9.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||436 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||When Should Low-dose Aspirin be Resumed After Peptic Ulcer Bleeding? A Randomized Controlled Trial|
|Estimated Study Start Date :||January 2, 2019|
|Estimated Primary Completion Date :||February 28, 2022|
|Estimated Study Completion Date :||February 28, 2022|
Experimental: Withold aspirin till after endoscopic haemostasis
Withhold the standard treatment of aspirin within 12 hours after endoscopic haemostasis.
Other: Resume Aspirin within 12 hours
Resume the standard treatment within 12 hours after endoscopic haemostasis
Active Comparator: Withold aspirin till 72 hours
Withhold the standard treatment of aspirin till 72 after endoscopic haemostasis.
Other: Resume Aspirin 72 - 84 hours
Resume the standard treatment between 72 and 84 hours after endoscopic haemostasis
- Recurrent peptic ulcer bleeding [ Time Frame: 30 days after endoscopic treatment ]Recurrent peptic ulcer bleeding within 30 days of endoscopic treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03785015
|Contact: Ka Man Kee, MPHfirstname.lastname@example.org|
|Contact: Jessica Ching, MPHemail@example.com|
|Principal Investigator:||Siew C Ng, MD||Chinese University of Hong Kong|