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


Phase 4
18 Years
80 Years
Open (Enrolling by invite only)
Both
Early Gastric Cancer, Gastric Dysplasia

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

delayed ulcer bleeding

Outcome Time Frame:

4 weeks

Safety Issue:

Yes

Principal Investigator

Hwoon-Yong Jung, professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Asan Medical Center

Authority:

Korea: Food and Drug Administration

Study ID:

PZ-1001-403-NS

NCT ID:

NCT01621451

Start Date:

June 2012

Completion Date:

June 2014

Related Keywords:

  • Early Gastric Cancer
  • Gastric Dysplasia
  • Hemorrhage
  • Stomach Neoplasms

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