Does Early Re-administration of Aspirin/Clopidogrel Increase the Risk of Bleeding From Artificial Ulcer After EMR or ESD?

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Hwoon-Yong Jung, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01621451
First received: June 13, 2012
Last updated: November 20, 2012
Last verified: November 2012
  Purpose

Aspirin and/or clopidogrel users are increasing due to increased prevalence of cardiovascular or cerebrovascular disease with an aging society in Korea. Also, the patients having endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) for early gastric cancer or gastric premalignant lesions including adenoma and dysplasia are increasing among aspirin and/or clopidogrel users. Practically, aspirin or clopidogrel is recommended to be stopped for 5~14 days before EMR or ESD because bleeding risk during or after procedure. And it is recommended to restart of aspirin and/or clopidogrel as soon as possible if immediate bleeding during or after the procedure is not occurred in consideration of thromboembolic risk. However, early restarting of aspirin and/or clopidogrel raise the risk of delayed bleeding and the risk of complications associated with delayed ulcer healing. Although it is important to determine the timing of restarting aspirin and/or clopidogrel in consideration of complications of post-EMR/ESD ulcer and thromboembolic risk, there is no definite guideline about the timing of restarting aspirin and/or clopidogrel.

This study is aimed to determine the timing of restarting aspirin and/or clopidogrel for the patients having EMR or ESD among aspirin and/or clopidogrel users. The investigators planned to compare the delayed bleeding rate and ulcer healing rate in patients with post-EMR/ESD ulcer when take proton pump inhibitor (pantoprazole 40 mg per day) between the patients restarting aspirin and/or clopidogrel within 3~4 days after the procedure and the patients restarting aspirin and/or clopidogrel 2 weeks after the procedure during 4 weeks. The primary endpoint is delayed ulcer bleeding rate at 4 weeks after EMR/ESD. The secondary end point is ulcer healing rate within 4 weeks.


Condition Intervention Phase
Early Gastric Cancer
Gastric Dysplasia
Drug: aspirin and/or clopidogrel
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Does Early Re-administration of Aspirin/Clopidogrel Increase the Risk of Bleeding From Artificial Ulcer After EMR or ESD?

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • delayed ulcer bleeding [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • ulcer healing rate [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: June 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: immediate
Patients who receive pantoprazole plus aspirin and/or clopidogrel within 3~4 days after EMR/ESD
Drug: aspirin and/or clopidogrel
Patients who have taken aspirin and/or clopidogrel and are found to have early gastric cancer or gastric premalignant lesions including adenoma and dysplasia by upper endoscopy will be stopped aspirin and/or clopidogrel for 7 days before EMR/ESD. In immediate group, the patient will receive oral proton pump inhibitor (pantoprazole 40mg per day) for 4 weeks after EMR/ESD to treat their post-EMR/ESD ulcer.
Active Comparator: 2 weeks
Patients who receive pantoprazole plus aspirin and/or clopidogrel at 2 weeks after EMR/ESD
Drug: aspirin and/or clopidogrel

Patients who have taken aspirin and/or clopidogrel and are found to have early gastric cancer or gastric premalignant lesions including adenoma and dysplasia by upper endoscopy will be stopped aspirin and/or clopidogrel for 7 days before EMR/ESD.

In 2 weeks group, the patient will receive oral proton pump inhibitor (pantoprazole 40mg per day) for 4 weeks after EMR/ESD to treat their post-EMR/ESD ulcer.


  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who have taken aspirin and/or clopidogrel for cardiovascular and/or cerebrovascular disease and are found to have early gastric cancer or premalignant lesions including adenoma and dysplasia by upper endoscopy.

Exclusion Criteria:

  • Patients with known coagulopathy or abnormal coagulation tests (prothrombin time, partial thromboplastin time and platelet count)
  • Patients receiving other antithrombotic, anticoagulant drugs
  • Patients needing continuation of nonsteroidal anti-inflammatory drugs, cyclooxygenase-2 (COX-2) inhibitors, or steroid after EMR/ESD
  • Patient with recent percutaneous coronary intervention (placement of drug eluting coronary artery stent within 12 months, bare metal coronary artery stents within 1 month)
  • Patient's age > 80 year-old or < 18 year-old
  • Patient with severe cardiovascular, pulmonary, hepatic, or renal disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01621451

Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Takeda
Investigators
Principal Investigator: Hwoon-Yong Jung, professor Asan Medical Center
  More Information

No publications provided

Responsible Party: Hwoon-Yong Jung, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01621451     History of Changes
Other Study ID Numbers: PZ-1001-403-NS
Study First Received: June 13, 2012
Last Updated: November 20, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Hemorrhage
Stomach Neoplasms
Pathologic Processes
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Aspirin
Ticlopidine
Clopidogrel
Pantoprazole
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014