NCT02418312

Brief Summary

Whether H2 receptor antagonist can prevent thienopyridine-related peptic ulcer remains unclear.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
228

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2012

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

April 12, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 16, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

March 11, 2019

Completed
Last Updated

March 11, 2019

Status Verified

March 1, 2019

Enrollment Period

5.8 years

First QC Date

April 12, 2015

Results QC Date

October 20, 2017

Last Update Submit

March 8, 2019

Conditions

Peptic Ulcer

Keywords

histamine-2 receptor antagonistpeptic ulcerthienopyridineprevention

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Healed Peptic Ulcer

    Follow-up endoscopy was performed at the end of the 6th month

    6 months

Study Arms (2)

histamine-2 receptor antagonist group

ACTIVE COMPARATOR

famotidine 40mg qd for 6 months.

Drug: histamine-2 receptor antagonist

placebo group

PLACEBO COMPARATOR

placebo for 6 months.

Drug: Placebo

Interventions

histamine-2 receptor antagonistDRUG

famotidine 40 mg qd plus thienopyridine

Also known as: famotidine 40 mg qd
histamine-2 receptor antagonist group
PlaceboDRUG

placebo plus thienopyridine

placebo group

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The past history of gastroduodenal ulcer and underwent endoscopy for dyspeptic symptoms.
  • thienopyridine users without baseline gastroduodenal ulcer at initial endoscopy.
  • They are adult patients aged least 20 years of age.

You may not qualify if:

  • They have a history of gastric or duodenal surgery other than oversewing of a perforation.
  • They require long-term treatment with non-steroidal anti-inflammatory drugs.
  • serious disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, 813, Taiwan

Location

Related Publications (23)

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    PMID: 11519503BACKGROUND

  • Bhatt DL, Fox KA, Hacke W, Berger PB, Black HR, Boden WE, Cacoub P, Cohen EA, Creager MA, Easton JD, Flather MD, Haffner SM, Hamm CW, Hankey GJ, Johnston SC, Mak KH, Mas JL, Montalescot G, Pearson TA, Steg PG, Steinhubl SR, Weber MA, Brennan DM, Fabry-Ribaudo L, Booth J, Topol EJ; CHARISMA Investigators. Clopidogrel and aspirin versus aspirin alone for the prevention of atherothrombotic events. N Engl J Med. 2006 Apr 20;354(16):1706-17. doi: 10.1056/NEJMoa060989. Epub 2006 Mar 12.

    PMID: 16531616BACKGROUND

  • Mehta SR, Yusuf S, Peters RJ, Bertrand ME, Lewis BS, Natarajan MK, Malmberg K, Rupprecht H, Zhao F, Chrolavicius S, Copland I, Fox KA; Clopidogrel in Unstable angina to prevent Recurrent Events trial (CURE) Investigators. Effects of pretreatment with clopidogrel and aspirin followed by long-term therapy in patients undergoing percutaneous coronary intervention: the PCI-CURE study. Lancet. 2001 Aug 18;358(9281):527-33. doi: 10.1016/s0140-6736(01)05701-4.

    PMID: 11520521BACKGROUND

  • CAPRIE Steering Committee. A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE). CAPRIE Steering Committee. Lancet. 1996 Nov 16;348(9038):1329-39. doi: 10.1016/s0140-6736(96)09457-3.

    PMID: 8918275BACKGROUND

  • Fork FT, Lafolie P, Toth E, Lindgarde F. Gastroduodenal tolerance of 75 mg clopidogrel versus 325 mg aspirin in healthy volunteers. A gastroscopic study. Scand J Gastroenterol. 2000 May;35(5):464-9. doi: 10.1080/003655200750023705.

    PMID: 10868447BACKGROUND

  • Ng FH, Wong SY, Chang CM, Chen WH, Kng C, Lanas AI, Wong BC. High incidence of clopidogrel-associated gastrointestinal bleeding in patients with previous peptic ulcer disease. Aliment Pharmacol Ther. 2003 Aug 15;18(4):443-9. doi: 10.1046/j.1365-2036.2003.01693.x.

    PMID: 12940930BACKGROUND

  • Chan FK, Ching JY, Hung LC, Wong VW, Leung VK, Kung NN, Hui AJ, Wu JC, Leung WK, Lee VW, Lee KK, Lee YT, Lau JY, To KF, Chan HL, Chung SC, Sung JJ. Clopidogrel versus aspirin and esomeprazole to prevent recurrent ulcer bleeding. N Engl J Med. 2005 Jan 20;352(3):238-44. doi: 10.1056/NEJMoa042087.

    PMID: 15659723BACKGROUND

  • Ma L, Elliott SN, Cirino G, Buret A, Ignarro LJ, Wallace JL. Platelets modulate gastric ulcer healing: role of endostatin and vascular endothelial growth factor release. Proc Natl Acad Sci U S A. 2001 May 22;98(11):6470-5. doi: 10.1073/pnas.111150798. Epub 2001 May 15.

    PMID: 11353854BACKGROUND

  • Hsu PI, Lai KH, Liu CP. Esomeprazole with clopidogrel reduces peptic ulcer recurrence, compared with clopidogrel alone, in patients with atherosclerosis. Gastroenterology. 2011 Mar;140(3):791-8. doi: 10.1053/j.gastro.2010.11.056. Epub 2010 Dec 7.

    PMID: 21144850BACKGROUND

  • Laine L, Hennekens C. Proton pump inhibitor and clopidogrel interaction: fact or fiction? Am J Gastroenterol. 2010 Jan;105(1):34-41. doi: 10.1038/ajg.2009.638. Epub 2009 Nov 10.

    PMID: 19904241BACKGROUND

  • Sibbing D, Kastrati A. Risk of combining PPIs with thienopyridines: fact or fiction? Lancet. 2009 Sep 19;374(9694):952-954. doi: 10.1016/S0140-6736(09)61562-2. Epub 2009 Aug 31. No abstract available.

    PMID: 19726077BACKGROUND

  • Gilard M, Arnaud B, Cornily JC, Le Gal G, Lacut K, Le Calvez G, Mansourati J, Mottier D, Abgrall JF, Boschat J. Influence of omeprazole on the antiplatelet action of clopidogrel associated with aspirin: the randomized, double-blind OCLA (Omeprazole CLopidogrel Aspirin) study. J Am Coll Cardiol. 2008 Jan 22;51(3):256-60. doi: 10.1016/j.jacc.2007.06.064.

    PMID: 18206732BACKGROUND

  • Simon T, Verstuyft C, Mary-Krause M, Quteineh L, Drouet E, Meneveau N, Steg PG, Ferrieres J, Danchin N, Becquemont L; French Registry of Acute ST-Elevation and Non-ST-Elevation Myocardial Infarction (FAST-MI) Investigators. Genetic determinants of response to clopidogrel and cardiovascular events. N Engl J Med. 2009 Jan 22;360(4):363-75. doi: 10.1056/NEJMoa0808227. Epub 2008 Dec 22.

    PMID: 19106083BACKGROUND

  • Ho PM, Maddox TM, Wang L, Fihn SD, Jesse RL, Peterson ED, Rumsfeld JS. Risk of adverse outcomes associated with concomitant use of clopidogrel and proton pump inhibitors following acute coronary syndrome. JAMA. 2009 Mar 4;301(9):937-44. doi: 10.1001/jama.2009.261.

    PMID: 19258584BACKGROUND

  • Juurlink DN, Gomes T, Ko DT, Szmitko PE, Austin PC, Tu JV, Henry DA, Kopp A, Mamdani MM. A population-based study of the drug interaction between proton pump inhibitors and clopidogrel. CMAJ. 2009 Mar 31;180(7):713-8. doi: 10.1503/cmaj.082001. Epub 2009 Jan 28.

    PMID: 19176635BACKGROUND

  • Taha AS, Hudson N, Hawkey CJ, Swannell AJ, Trye PN, Cottrell J, Mann SG, Simon TJ, Sturrock RD, Russell RI. Famotidine for the prevention of gastric and duodenal ulcers caused by nonsteroidal antiinflammatory drugs. N Engl J Med. 1996 May 30;334(22):1435-9. doi: 10.1056/NEJM199605303342204.

    PMID: 8618582BACKGROUND

  • Hudson N, Taha AS, Russell RI, Trye P, Cottrell J, Mann SG, Swanell AJ, Sturrock RD, Hawkey CJ. Famotidine for healing and maintenance in nonsteroidal anti-inflammatory drug-associated gastroduodenal ulceration. Gastroenterology. 1997 Jun;112(6):1817-22. doi: 10.1053/gast.1997.v112.pm9178671.

    PMID: 9178671BACKGROUND

  • Taha AS, Dahill S, Morran C, Hudson N, Hawkey CJ, Lee FD, Sturrock RD, Russell RI. Neutrophils, Helicobacter pylori, and nonsteroidal anti-inflammatory drug ulcers. Gastroenterology. 1999 Feb;116(2):254-8. doi: 10.1016/s0016-5085(99)70120-4.

    PMID: 9922304BACKGROUND

  • Taha AS, McCloskey C, Prasad R, Bezlyak V. Famotidine for the prevention of peptic ulcers and oesophagitis in patients taking low-dose aspirin (FAMOUS): a phase III, randomised, double-blind, placebo-controlled trial. Lancet. 2009 Jul 11;374(9684):119-25. doi: 10.1016/S0140-6736(09)61246-0. Epub 2009 Jul 3.

    PMID: 19577798BACKGROUND

  • Ng FH, Wong SY, Lam KF, Chu WM, Chan P, Ling YH, Kng C, Yuen WC, Lau YK, Kwan A, Wong BC. Famotidine is inferior to pantoprazole in preventing recurrence of aspirin-related peptic ulcers or erosions. Gastroenterology. 2010 Jan;138(1):82-8. doi: 10.1053/j.gastro.2009.09.063. Epub 2009 Nov 11.

    PMID: 19837071BACKGROUND

  • Hsu PI, Lai KH, Wu CJ, Tseng HH, Tsay FW, Peng NJ, Chen TA, Chuah SK, Lin WS, Lo GH. High-dose versus low-dose esomeprazole-based triple therapy for Helicobacter pylori infection. Eur J Clin Invest. 2007 Sep;37(9):724-30. doi: 10.1111/j.1365-2362.2007.01852.x.

    PMID: 17696962BACKGROUND

MeSH Terms

Conditions

Peptic Ulcer

Interventions

Histamine H2 AntagonistsFamotidine

Condition Hierarchy (Ancestors)

Duodenal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Histamine AntagonistsHistamine AgentsNeurotransmitter AgentsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesPhysiological Effects of DrugsThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Limitations and Caveats

The trial was performed in a single country

Results Point of Contact

Title
Dr. Ping-I Hsu
Organization
Kaohsiung Veterans General Hospital
pihsu@vghks.gov.tw
+886-7-3422121

Study Officials

  • Ping-I Hsu, Bachelor

    Kaohsiung Veterans General Hospital.

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 12, 2015

First Posted

April 16, 2015

Study Start

January 1, 2012

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

March 11, 2019

Results First Posted

March 11, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)