NCT02840929

Brief Summary

OBJECTIVES: Up to 15% of patients with peptic ulcer bleeding will develop rebleeding, mainly in those with ulcers of higher-risk stigmata (i.e. Forrest class Ia to IIb). Randomized trials show that second-look endoscopy is effective in reducing rebleeding rate. However, whether to withhold aspirin or other anti-platelet agents (for the treatment of established cardiovascular or cerebrovascular diseases) remains controversial. Studies have shown that although continuation of anti-platelet agents reduces mortality rate due to reduced cardiovascular and cerebrovascular events, there is a marginal increase in rebleeding risk. HYPOTHESIS: We hypothesize that continuation of aspirin or other anti-platelet agents coupled with second-look endoscopy could reduce the rebleeding rate without increasing the risk of thromboembolic events in high-risk patients.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Geographic Reach
2 countries

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

November 29, 2017

Status Verified

November 1, 2017

Enrollment Period

1.2 years

First QC Date

July 19, 2016

Last Update Submit

November 28, 2017

Conditions

OGDGastric Ulcer Induced by Anti-platelet AgentDuodenal Ulcer Induced by Anti-platelet Agent

Outcome Measures

Primary Outcomes (1)

  • Rebleeding

    Detect difference in the rate of rebleeding within 30 days of primary esophagogastroduodenoscopy (OGD) Rebleeding is suspected clinically by the presence of fresh haematemesis, or haematochezia/melaena after a normal stool, or unstable haemodynamics with systolic blood pressure ≤ 90 mmHg or pulse ≥ 100 beats/min (after ruling out other causes of shock, e.g. cardiogenic or septic shock), or a drop in haemoglobin level by 2 g/dL or more within 24 hours despite transfusion of 2 or more units of blood during the same period. If any one of the features is present, we will perform emergency endoscopy to confirm the diagnosis of recurrent peptic ulcer bleeding by either the persistence of ulcers of high-risk stigma or fresh blood in the stomach). Rebleeding is only defined if it is confirmed by the presence of both clinical and endoscopic features.

    30 days

Secondary Outcomes (6)

  • cardiovascular/cerebrovascular events

    30 days

  • all-cause mortality

    30 days

  • days of hospital stay

    30 days

  • units of packed cell transfused

    30 days

  • radiological and/or surgical interventions (as documented in Clinical Management System and medical records)

    30 days

  • +1 more secondary outcomes

Study Arms (2)

Second-look OGD group

EXPERIMENTAL

Second-look OGD within 16 to 24 hours after primary OGD, in addition to standard care (esomeprazole infusion for three days, followed by oral esomeprazole. OGD will be offered if signs of rebleeding present)

Procedure: Second-look OGDDrug: Esomeprazole

Standard care group

ACTIVE COMPARATOR

Esomeprazole infusion for three days, followed by oral esomeprazole. OGD will be offered if signs of rebleeding present

Drug: Esomeprazole

Interventions

Second-look OGDPROCEDURE

Second-look OGD within 16 to 24 hours after primary OGD

Second-look OGD group
EsomeprazoleDRUG
Second-look OGD groupStandard care group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Antiplatelet for both primary and secondary prophylaxis
  • Peptic ulcers of Forrest class Ia (spurting of blood), Ib (oozing of blood), IIa (visible vessel) \& IIb (adherent clot)

You may not qualify if:

  • Peptic ulcers of class IIc (pigmented ulcer base) \& III (clean ulcer base)
  • Unsuccessful endoscopic hemostasis
  • Ulcer perforation
  • Gastric outlet obstruction precluding passage of scope to D2
  • Malignant ulcers
  • Proton pump inhibitor (PPI) allergy
  • Concomitant anticoagulants
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Queen Mary Hospital

Hong Kong, China

Location

Queen Mary Hospital

Hong Kong, 0, Hong Kong

Location

MeSH Terms

Interventions

Esomeprazole

Intervention Hierarchy (Ancestors)

Omeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Ka Shing Cheung, MBBS

    Queen Mary Hospital, Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 19, 2016

First Posted

July 21, 2016

Study Start

July 1, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

November 29, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)HK(1)