Prevention of stroke and systemic embolism with rivaroxaban compared with warfarin in Chinese patients with atrial fibrillation

Vascular ◽  
2013 ◽  
Vol 22 (4) ◽  
pp. 252-258 ◽  
Author(s):  
Lizheng Mao ◽  
Chengyan Li ◽  
Tao Li ◽  
Kunxiong Yuan
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Trial ◽  
Safety Concern ◽  
Hazard Ratio ◽  
Chinese Patients ◽  
Systemic Embolism ◽  
Double Blind ◽  
Warfarin Group ◽  
Double Blind Clinical Trial ◽  
To Receive

This study assessed the effects and safety of rivaroxaban versus warfarin in Chinese patients with atrial fibrillation. In this double-blind clinical trial, a total of 353 consecutive patients with atrial fibrillation who were at risk of stroke or systemic embolism were enrolled to receive either rivaroxaban or warfarin. The primary effect endpoint occurred in five patients in the rivaroxaban group (2.29% per year) and in seven patients in the warfarin group (2.91% per year) (hazard ratio with warfarin, 0.76, 95% CI, 0.64–0.91; p = 0.03). Major and non-major clinically relevant bleeding occurred in 38 patients (14.3% per year) in the rivaroxaban group and in 36 patients (13.7% per year) in the warfarin group (hazard ratio rivaroxaban versus warfarin, 1.07; 95% CI, 0.93–1.14; p = 0.39). Adverse events were similar between these two arms ( p > 0.05). In conclusion, oral administration of rivaroxaban reduced the risk of stroke or systemic embolism without significantly increasing the safety concern.

scholarly journals Effects of apixaban compared with warfarin as gain in event-free time – a novel assessment of the results of the ARISTOTLE trial

2019 ◽  
Vol 27 (12) ◽  
pp. 1311-1319 ◽  
Author(s):  
Erik Berglund ◽  
Lars Wallentin ◽  
Jonas Oldgren ◽  
Henrik Renlund ◽  
John H Alexander ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Intracranial Bleeding ◽  
Free Time ◽  
Systemic Embolism ◽  
Bleeding Events ◽  
Double Blind ◽  
Warfarin Group ◽  
Novel Approach ◽  
Atrial Fibrillation Trial

Background A novel approach to determine the effect of a treatment is to calculate the delay of event, which estimates the gain of event-free time. The aim of this study was to estimate gains in event-free time for stroke or systemic embolism, death, bleeding events, and the composite of these events, in patients with atrial fibrillation randomized to either warfarin or apixaban in the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation trial (ARISTOTLE). Design The ARISTOTLE study was a randomized double-blind trial comparing apixaban with warfarin. Methods Laplace regression was used to estimate the delay in time to the outcomes between the apixaban and the warfarin group in 6, 12, 18 and 22 months of follow-up. Results The gain in event-free time for apixaban versus warfarin was 181 (95% confidence interval 76 to 287) days for stroke or systemic embolism and 55 (–4 to 114) days for death after 22 months of follow-up. The corresponding gains in event-free times for major and intracranial bleeding were 206 (130 to 281) and 392 (249 to 535) days, respectively. The overall gain for the composite of all these events was a gain of 116 (60 to 171) days. Conclusions In patients with atrial fibrillation, 22 months of treatment with apixaban, as compared with warfarin, provided gains of approximately 6 months in event-free time for stroke or systemic embolism, 7 months for major bleeding and 13 months for intracranial bleeding.

scholarly journals The efficacy, safety, and tolerability of levofloxacin quadruple therapy for helicobacter pylori eradication: a randomized, double-blind clinical trial

2020 ◽  
Author(s):  
Fariborz Mansour-Ghanaei ◽  
Behnam Masihypour ◽  
Mohammad Fathalipour ◽  
Soheil Hassanipour ◽  
Homayoon Sokhanvar ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Helicobacter Pylori ◽  
Alternative Therapy ◽  
Double Blind ◽  
Intention To Treat ◽  
Bismuth Subcitrate ◽  
Double Blind Clinical Trial ◽  
End Of Treatment ◽  
H Pylori ◽  
To Receive

Abstract BackgroundThe incidence of microbial resistance is increasing, and new rescue regimens are needed in order to treat Helicobacter pylori (H. pylori) infection. To evaluate the efficacy, safety, and tolerability of levofloxacin based quadruple therapies in the eradication of H. pylori.MethodsIn a randomized, double-blind clinical trial, 220 patients with dyspepsia and H. pylori infection were randomly assigned to receive either bismuth subcitrate 240 mg, pantoprazole 20 mg, amoxicillin 1000 mg twice a day, and levofloxacin 500 mg daily for seven days (BPAL-7), or ten days (BPAL-10). The eradication of H. pylori was evaluated two months after the end of treatment, and adverse drug reactions (ADRs) were assessed during the intervention.ResultsAccording to intention-to-treat and per-protocol, the eradication rate was significantly lower in the BPAL-7 regimen 49.1% (95% CI: 39.3–57.8) and 47.6% (95% CI: 39.7–58.4), respectively compared to the BPAL- 10 regimen 62.7% (95% CI: 53.6–72.8) and 62.4% (95% CI: 55.1–72.8), respectively. The incidence of ADRs was not statistically significant between BPAL-7 (33.6%) and BPAL-10 (36.7%) groups.ConclusionAlthough the ADRs were negligible in both groups, these regimens could not be an ideal alternative therapy for H. pylori because of low eradication rates compared to standard regimens.Trial registration: The study reviewed and approved by the Iranian Registry of Clinical Trials (IRCT201406141155N19). This trial was retrospectively registered on July 10, 2015.

scholarly journals The Efficacy, Safety, And Tolerability of Levofloxacin Quadruple Therapy For Helicobacter Pylori Eradication: A Randomized, Double-Blind Clinical Trial

2021 ◽  
Author(s):  
Fariborz Mansour-Ghanaei ◽  
Behnam Masihypour ◽  
Mohammad Fathalipour ◽  
Soheil Hassanipour ◽  
Homayoon Sokhanvar ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Helicobacter Pylori ◽  
Alternative Therapy ◽  
Double Blind ◽  
Intention To Treat ◽  
Bismuth Subcitrate ◽  
Double Blind Clinical Trial ◽  
End Of Treatment ◽  
H Pylori ◽  
To Receive

Abstract The incidence of microbial resistance is increasing, and new rescue regimens are needed in order to treat Helicobacter pylori (H. pylori) infection. To evaluate the efficacy, safety, and tolerability of levofloxacin based quadruple therapies in the eradication of H. pylori. In a randomized, double-blind clinical trial, 220 patients with dyspepsia and H. pylori infection were randomly assigned to receive either bismuth subcitrate 240 mg, pantoprazole 20 mg, amoxicillin 1000 mg twice a day, and levofloxacin 500 mg daily for seven days (BPAL-7), or ten days (BPAL-10). The eradication of H. pylori was evaluated two months after the end of treatment, and adverse drug reactions (ADRs) were assessed during the intervention. According to intention-to-treat and per-protocol, the eradication rate was significantly lower in the BPAL-7 regimen 49.1 % (95 % CI: 39.3-57.8) and 47.6 % (95 % CI: 39.7-58.4), respectively compared to the BPAL- 10 regimen 62.7 % (95 % CI: 53.6-72.8) and 62.4 % (95 % CI: 55.1-72.8), respectively. The incidence of ADRs was not statistically significant between BPAL-7 (33.6 %) and BPAL-10 (36.7 %) groups. Although the ADRs were negligible in both groups, these regimens could not be an ideal alternative therapy for H. pylori because of low eradication rates compared to standard regimens.Trial registration: The study reviewed and approved by the Iranian Registry of Clinical Trials (IRCT201406141155N19).

scholarly journals Effectiveness and Adverse Effects of Tranexamic Acid in Bleeding during Adenotonsillectomy: A Randomized, Controlled, Double-blind Clinical Trial

2021 ◽  
Author(s):  
Marco Aurélio Fornazieri ◽  
Henrique Kazuo Lima Kubo ◽  
Lisandra Coneglian de Farias ◽  
Adriano Morita Fernandes da Silva ◽  
Ellen Cristine Duarte Garcia ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Effects ◽  
Tranexamic Acid ◽  
Postoperative Bleeding ◽  
Group Versus ◽  
Double Blind ◽  
Randomized Controlled ◽  
Bleeding Volume ◽  
Double Blind Clinical Trial ◽  
To Receive

Abstract Introduction Intra and postoperative bleeding are the most frequent and feared complications in adenotonsillectomy (AT). Tranexamic acid (TXA), which is known for its antifibrinolytic effects, has a proven benefit in reducing bleeding in hemorrhagic trauma and cardiac surgery; however, the effectiveness and timing of its application in AT have not yet been established. Objectives We aimed to evaluate the efficacy of TXA in controlling bleeding during and after AT and assess its possible adverse effects in children. Methods The present randomized, controlled, double-blind clinical trial included 63 children aged 2 to 12 years. They were randomly assigned to receive either intravenous TXA (10 mg/kg) or placebo 10 minutes before surgery. The volume of intraoperative bleeding, presence of postoperative bleeding, and adverse effects during and 8 hours after the surgery were assessed. Results No difference in bleeding volume was noted between the 2 groups (mean, 122.7 ml in the TXA group versus 115.5 ml in the placebo group, p = 0.36). No intraoperative or postoperative adverse effects were noted because of TXA use. Furthermore, no primary or secondary postoperative bleeding was observed in any of the participants. Conclusion In our pediatric sample, TXA (10 mg/kg) administration before AT was safely used, without any adverse effects. It did not reduce the bleeding volume in children during this type of surgery. Future studies should assess the use of higher doses of TXA and its administration at other time points before or during surgery.

scholarly journals Perioperative synbiotics administration decreases postoperative infections in patients with colorectal cancer: a randomized, double-blind clinical trial

2017 ◽  
Vol 44 (6) ◽  
pp. 567-573 ◽  
Author(s):  
ALINE TABORDA FLESCH ◽  
STAEL T. TONIAL ◽  
PAULO DE CARVALHO CONTU ◽  
DANIEL C. DAMIN
Keyword(s):  
Colorectal Cancer ◽  
Clinical Trial ◽  
Elective Surgery ◽  
Lactobacillus Rhamnosus ◽  
Control Group ◽  
Double Blind ◽  
Double Blind Clinical Trial ◽  
Colorectal Cancer Patients ◽  
To Receive

ABSTRACT Objective: to evaluate the effect of perioperative administration of symbiotics on the incidence of surgical wound infection in patients undergoing surgery for colorectal cancer. Methods: We conducted a randomized clinical trial with colorectal cancer patients undergoing elective surgery, randomly assigned to receive symbiotics or placebo for five days prior to the surgical procedure and for 14 days after surgery. We studied 91 patients, 49 in the symbiotics group (Lactobacillus acidophilus 108 to 109 CFU, Lactobacillus rhamnosus 108 to 109 CFU, Lactobacillus casei 108 to 109 CFU, Bifi dobacterium 108 to 109 CFU and fructo-oligosaccharide (FOS) 6g) and 42 in the placebo group. Results: surgical site infection occurred in one (2%) patient in the symbiotics group and in nine (21.4%) patients in the control group (p=0.002). There were three cases of intraabdominal abscess and four cases of pneumonia in the control group, whereas we observed no infections in patients receiving symbiotics (p=0.001). Conclusion: the perioperative administration of symbiotics significantly reduced postoperative infection rates in patients with colorectal cancer. Additional studies are needed to confirm the role of symbiotics in the surgical treatment of colorectal cancer.

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