Clinical trial NCT02317445: Relationship of Helicobacter Pylori Eradication Therapy and Long-term Outcome in Acute Coronary Syndrome
Official title: Beijing Tiantan Hospital,Capital Medical University.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Keywords: helicobacter pylori
eradication therapy
major adverse cardiac events
long-term outcome
To explore the significance of Hp eradication therapy in preventing major adverse cardiac events (MACE) and upper gastrointestinal bleeding (UGIB).
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2014-12-16
Enrollment: 472
Sex: ALL
Minimum age (years): 50
Maximum age (years): 73
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study is a single-center and random analysis. The consecutive hospitalized patients with ACS at Beijing Mentougou District Hospital from January 1, 2008 to December 31, 2010 were enrolled. Figure 1 is a flow diagram of the trial. There were 259 males (54.9%) and 213 females (45.1%) with an average age of 61.1 ± 11.0 years. Patient's history, physical examination, and laboratory results were recorded. All patients were divided into the Hp-negative group (Hp-, group 1.) and the Hp-positive group (Hp+). The Hp+ group were randomly divided into two groups: Group 2, the Hp+ with eradication therapy (Hp+ Therapy); and Group 3, the Hp+ without eradication therapy (Hp+No Therapy).

Brief summary: Objective: To investigate the relationship between Helicobacter pylori (Hp) infection and the prognosis of acute coronary syndrome (ACS) in a Chinese population and to explore the significance of Hp eradication therapy in preventing major adverse cardiac events (MACE) and upper gastrointestinal bleeding (UGIB) in patients on dual antiplatelet treatment. Methods: To analyze 472 ACS patients with drug-eluting stent (DES) implantation from January 1, 2008 to December 31, 2010 in the department of cardiology at Beijing Mentougou District Hospital. Patients were divided into three groups: Group 1, the Hp-negative patients (Hp-); Group 2, the Hp-positive patients with eradication therapy (Hp+ Therapy); and Group 3, the Hp-positive patients without eradication therapy (Hp+ No Therapy). All patients took 13C urea breath test, high sensitive C-reactive protein (hs-CRP)，homocysteine (HCY) and other biochemical indicators. The investigators explored the correlations of Hp eradication therapy with MACE (including recurrent myocardial infarction, revascularization and death) and UGIB after 3 to 5 years of follow-up using survival analysis.

Detailed description: This study is a single-center and random analysis. The consecutive hospitalized patients with ACS at Beijing Mentougou District Hospital from January 1, 2008 to December 31, 2010 were enrolled. Figure 1 is a flow diagram of the trial. There were 259 males (54.9%) and 213 females (45.1%) with an average age of 61.1 ± 11.0 years. Patient's history, physical examination, and laboratory results were recorded. All patients were divided into the Hp-negative group (Hp-, group 1.) and the Hp-positive group (Hp+). The Hp+ group were randomly divided into two groups: Group 2, the Hp+ with eradication therapy (Hp+ Therapy); and Group 3, the Hp+ without eradication therapy (Hp+No Therapy).

Eligibility criteria: Inclusion Criteria:

* Patients were diagnosed acute coronary syndrome according to the 2012 ESC guidlines.
* All the patients took dual antiplatelet therapy after implanting drug eluting stent (DES) during hospitalization and had no any digestive symptoms.

Exclusion Criteria:

* Subjects who had suffered gastrointestinal bleeding within one week.
* Subjects had a history of gastrectomy, cardiac insufficiency, thyroid dysfunction, and any ongoing infections were eliminated.
* Patients with the use of antibiotics, bismuth, or sucralfate within one month and without impanting DES because of ACS during hospitalization were also excluded.
* Those who had gastrointestinal symptoms, such as acid reflux, heartburn, nausea, vomiting, stomach ache and diarrhea, or had a confirmed peptic ulcer with Hp infection were excluded because these patients may be taken gastroenterology treatment.

Primary outcomes:
measure: Comparison of the MACE among the three groups.
timeFrame: January 1, 2008 to December 31, 2013, up to 6 years
Secondary outcomes:
measure: Comparison of the upper gastrointestinal bleeding among the three groups.
timeFrame: January 1, 2008 to December 31, 2013, up to 6 years
Other outcomes:
Locations:
Study officials:
References:
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