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Trial record 27 of 407 for:    ASPIRIN AND clopidogrel AND Purinergic Antagonists

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

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ClinicalTrials.gov Identifier: NCT01621451
Recruitment Status : Unknown
Verified November 2012 by Hwoon-Yong Jung, Asan Medical Center.
Recruitment status was:  Enrolling by invitation
First Posted : June 18, 2012
Last Update Posted : November 22, 2012
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Hwoon-Yong Jung, Asan Medical Center

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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?
Study Start Date : June 2012
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.





Primary Outcome Measures :
  1. delayed ulcer bleeding [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. ulcer healing rate [ Time Frame: 4 weeks ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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): NCT01621451


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

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Responsible Party: Hwoon-Yong Jung, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01621451     History of Changes
Other Study ID Numbers: PZ-1001-403-NS
First Posted: June 18, 2012    Key Record Dates
Last Update Posted: November 22, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
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Aspirin
Clopidogrel
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Pantoprazole
Proton Pump Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors