When Should Low-dose Aspirin be Resumed After Peptic Ulcer Bleeding?

NCT03785015 | Unknown DMC

• 1 other identifier: ReASA
• Study Type: interventional
• Target: 436
• Locations: 1 country
• Sites: 1

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.

Conditions

Aspirin; GastroIntestinal Bleeding

Outcome Measures

Primary Outcomes (1)

• Recurrent peptic ulcer bleeding

  Recurrent peptic ulcer bleeding within 30 days of endoscopic treatment

  30 days after endoscopic treatment

Study Arms (2)

Withold aspirin till after endoscopic haemostasis

EXPERIMENTAL

Withhold the standard treatment of aspirin within 12 hours after endoscopic haemostasis.

Other: Resume Aspirin within 12 hours

Withold aspirin till 72 hours

ACTIVE COMPARATOR

Withhold the standard treatment of aspirin till 72 after endoscopic haemostasis.

Other: Resume Aspirin 72 - 84 hours

Interventions

Resume Aspirin within 12 hours OTHER

Resume the standard treatment within 12 hours after endoscopic haemostasis

Withold aspirin till after endoscopic haemostasis

Resume Aspirin 72 - 84 hours OTHER

Resume the standard treatment between 72 and 84 hours after endoscopic haemostasis

Withold aspirin till 72 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Beijing Friendship Hospital: collaborator
• National Taiwan University Hospital: collaborator

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Siew C Ng, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ka Man Kee, MPH

CONTACT

85235053855; carmenkee@cuhk.edu.hk

Jessica Ching, MPH

CONTACT

85235053524; jessicaching@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: December 24, 2018
• Study Start: January 14, 2019
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: October 22, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)