When Should Low-dose Aspirin be Resumed After Peptic Ulcer Bleeding?
Primary Purpose
Aspirin, GastroIntestinal Bleeding
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Resume Aspirin within 12 hours
Resume Aspirin 72 - 84 hours
Sponsored by
About this trial
This is an interventional prevention trial for Aspirin
Eligibility Criteria
Inclusion Criteria:
- Age >18
- Patients with actively bleeding gastroduodenal lesions (peptic ulcer, bleeding erosions, or Dieulafoy's lesion) or ulcers showing other high risk stigmata (visible blood vessels or adherent clots) treated by endoscopic therapy
- Subjects continue to require regular ASA or dual anti-platelet therapy for treatment of CV or cerebrovascular diseases after this bleeding episode
Exclusion Criteria:
- Patients who received ASA for primary prophylaxis
- Unsuccessful endoscopic hemostasis of bleeding ulcers or ulcer perforation
- Gastric outlet obstruction
- Known sensitivity to PPIs
- Previous partial gastrectomy or vagotomy
- Patients need concomitant anticoagulant
- Pregnant unless sterilization, menopause or last menstrual period within 7 days
- Other co-morbidities or advanced age that will hinder the drug compliance or follow up
- Malignancy on active treatment
- Unable to give consent
Sites / Locations
- Prince of Wales HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Withold aspirin till after endoscopic haemostasis
Withold aspirin till 72 hours
Arm Description
Withhold the standard treatment of aspirin within 12 hours after endoscopic haemostasis.
Withhold the standard treatment of aspirin till 72 after endoscopic haemostasis.
Outcomes
Primary Outcome Measures
Recurrent peptic ulcer bleeding
Recurrent peptic ulcer bleeding within 30 days of endoscopic treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT03785015
First Posted
December 20, 2018
Last Updated
October 20, 2020
Sponsor
Chinese University of Hong Kong
Collaborators
Beijing Friendship Hospital, National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03785015
Brief Title
When Should Low-dose Aspirin be Resumed After Peptic Ulcer Bleeding?
Official Title
When Should Low-dose Aspirin be Resumed After Peptic Ulcer Bleeding? A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Recruiting
Study Start Date
January 14, 2019 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
Collaborators
Beijing Friendship Hospital, National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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. After endoscopic control of ulcer bleeding, most patients with cardiovascular (CV) diseases will need to resume ASA. However, the investigator found that immediate resumption of ASA saves life but at the expense of higher risk of recurrent bleeding. Peptic ulcer bleeding associated with ASA is a major cause of hospitalization in Hong Kong. Currently, ASA use has contributed to about one-third of the bleeding ulcers admitted to our hospital that serves a local population of 1.5 million. Accordingly, current international guidelines recommend early resumption of ASA but the optimal timing is unknown. 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. The investigator proposes a open-label randomized-controlled trial to evaluate the optimal timing of resuming ASA in patients with CV diseases complicated by peptic ulcer bleeding. Patients will be randomized to resume the standard treatment within first few hours or only to resume the standard treatment 72 hours after endoscopic haemostasis.
Detailed Description
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, the investigator 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.
The investigator aims 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.
References
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aspirin, GastroIntestinal Bleeding
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
436 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Withold aspirin till after endoscopic haemostasis
Arm Type
Experimental
Arm Description
Withhold the standard treatment of aspirin within 12 hours after endoscopic haemostasis.
Arm Title
Withold aspirin till 72 hours
Arm Type
Active Comparator
Arm Description
Withhold the standard treatment of aspirin till 72 after endoscopic haemostasis.
Intervention Type
Other
Intervention Name(s)
Resume Aspirin within 12 hours
Intervention Description
Resume the standard treatment within 12 hours after endoscopic haemostasis
Intervention Type
Other
Intervention Name(s)
Resume Aspirin 72 - 84 hours
Intervention Description
Resume the standard treatment between 72 and 84 hours after endoscopic haemostasis
Primary Outcome Measure Information:
Title
Recurrent peptic ulcer bleeding
Description
Recurrent peptic ulcer bleeding within 30 days of endoscopic treatment
Time Frame
30 days after endoscopic treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age >18
Patients with actively bleeding gastroduodenal lesions (peptic ulcer, bleeding erosions, or Dieulafoy's lesion) or ulcers showing other high risk stigmata (visible blood vessels or adherent clots) treated by endoscopic therapy
Subjects continue to require regular ASA or dual anti-platelet therapy for treatment of CV or cerebrovascular diseases after this bleeding episode
Exclusion Criteria:
Patients who received ASA for primary prophylaxis
Unsuccessful endoscopic hemostasis of bleeding ulcers or ulcer perforation
Gastric outlet obstruction
Known sensitivity to PPIs
Previous partial gastrectomy or vagotomy
Patients need concomitant anticoagulant
Pregnant unless sterilization, menopause or last menstrual period within 7 days
Other co-morbidities or advanced age that will hinder the drug compliance or follow up
Malignancy on active treatment
Unable to give consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ka Man Kee, MPH
Phone
85235053855
Email
carmenkee@cuhk.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Ching, MPH
Phone
85235053524
Email
jessicaching@cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Siew C Ng, MD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Siew Chien Ng, PhD
Phone
35053996
Email
siewchienng@cuhk.edu.hk
12. IPD Sharing Statement
Plan to Share IPD
No
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When Should Low-dose Aspirin be Resumed After Peptic Ulcer Bleeding?
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