Proton Pump Inhibitor Clinical Trial
Official title:
Evaluation of the Efficacy and Safety of Different Duration of Proton Pump Inhibitor for Prevention of Upper Gastrointestinal Mucosal Injury in Patients Taking 12-month Dual Antiplatelet Therapy After Coronary Artery Bypass Graft Surgery
The purpose of this study is to determine whether 12-month prophylactic treatment with pantoprazole is superior to 1-month therapy without major cardiovascular events (MACE) increased significantly, in prevention of dual antiplatelet therapy (DAPT)-induced upper gastrointestinal (GI) mucosal injury after coronary artery bypass graft (CABG) surgery. The potentially serious harm of DAPT on gastroduodenal mucosa will be assessed by esophagogastroduodenoscopy (EGD).
Endoscopic evaluation of gastroduodenal mucosal injury:
Based on the modified Lanza score, the new endoscopic evaluation system established in the
DACAB-GI-1 study includes 6 grades of mucosal injuries. Grade 0: normal mucosa; Grade 1:
erythema or petechiae only; Grade 2: 1 to 2 erosive lesions; Grade 3: 3 to 10 erosive
lesions; Grade 4: more than 10 erosive lesions or small ulcers (diameter: 3-5mm); Grade 5: an
ulcer is greater than 5 mm in diameter. Comprehensive results of gastroduodenal mucosal
injury will be marked as G0-5 (G: gastro) and D0-5 (D: duodeno) together. Mild injury was
defined as level II or less. Severe injury was defined from level III to V, which should be
treated with proton pump inhibitor (PPI) to decrease the risk of upper GI bleeding. The new
level system is as following: Level 0: G0D0; Level I: G1D0-1/G0D1; Level II: G2D0-2/G0-1D2;
Level III: G3D0-3/G0-2D3; Level IV: G4D0-4/G0-3D4; Level V: G5D0-5/G0-4D5.
Sample size justification:
Until now, no published data or reference is available for the efficacy of pantoprazole when
concomitant use with DAPT. The results from the preliminary study (DACAB-GI-1) showed that
the percentage of serious gastroduodenal mucosal lesions (Level III-V) in patients treated
with PPIs for 1, 3 and more than 6 months were 36.76%, 28.45% and 17.65%, respectively.
Therefore, the efficacy difference of pantoprazole is estimated to be 18% between 2 groups.
The average incidence of gastroduodenal mucosal injury is estimated to be 36% in the control
group (1-month therapy of pantoprazole), and the corresponding incidence in the experimental
group (12-month therapy of pantoprazole) is estimated to be 18%.
The determination of minimal sample size is as following: Group sample sizes of 93 in the
experimental group and 93 in the control group achieve 80% power to detect a difference
between the group proportions of -18%. The proportion in the experimental group is assumed to
be 36% under the null hypothesis and 18% under the alternative hypothesis. The proportion in
the control group is 36%. The test statistic used is Pearson Chi-Squared test. The
significance level of the test was targeted at 0.05. The significance level actually achieved
by this design is 0.0522. Considering 10% of the lost and/or drop-out rate, the final sample
size estimated will be 104 in the experimental group and control group, respectively. The
total sample size is no less than 208.
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