scholarly journals INTENSIVE PHARMACOVIGILANCE STUDY, CARRIED OUT IN MEXICAN POPULATION WITH A HISTORY OF ACUTE MYOCARDIAL INFARCTION OR ANGINA TREATED WITH CLOPIDOGREL, GENERIC DRUG, FOR SECONDARY PROPHYLAXIS

2021 ◽  
Vol 10 (5) ◽  
pp. 3666-3672
Author(s):  
H A Arcelia
Keyword(s):  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Adverse Events ◽  
Generic Drug ◽  
Causal Relation ◽  
Oral Treatment ◽  
Fatal Outcome ◽  
Secondary Prophylaxis ◽  
Mexican Population ◽  
Vascular Events

The results obtained from an intensive pharmacovigilance, phase IV, single-center study, with an oral treatment for secondary prophylaxis of acute myocardial infarction or angina with clopidogrel, generic drug, in Mexican population, at a daily dose of 75 mg, alone or associated with acetylsalicylic acid, are described. A total of 60 patients were admitted; 10 patients were discontinued from the study due to different causes. The patients had, at least, 2 comorbidities in addition to heart disease. Among the most important history were obesity 40% and overweight 41.6%; the age range (tenths) with the greatest number of participants was 51 to 60 years with 25 patients, which represents 41.6%. A total of 247 adverse events were reported (57 patients had adverse events) of which 39 (15.7%) events were heart events, 32 (12.9%) vascular events; 14 (5.7%) events were serious, 9 (3.6%) of the serious events were heart events, 2 (0.8%) vascular events and 3 (1.2%) lithiasis; Of the 24 (9.7%) events, than were classified with a possible causal relation with clopidogrel, 1 (0.4%) was classified as serious. All the other events were non-serious. It was, therefore, concluded that generic clopidogrel is safe, and risk possibility should continue to be monitored for the type of disease that patients suffer and that may have a fatal outcome

Randomized, double blind, placebo-controlled, safety and efficacy study of dutogliptin in combination with filgrastim in early recovery post-MI: rationale, design and first interim analysis

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
D Von Lewinski ◽  
B Merkely ◽  
I Buysschaert ◽  
R.A Schatz ◽  
G.G Nagy ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Stem Cells ◽  
Adverse Events ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Funding Source ◽  
Early Recovery ◽  
Ventricular Ejection Fraction ◽  
Combined Application

Abstract Background Regenerative therapies offer new approaches to improve cardiac function after acute ST-elevation myocardial infarction (STEMI). Mobilization of stem cells and homing within the infarcted area have been identified as the key mechanisms for successful treatment. Application of granulocyte-colony stimulating factor (G-CSF) is the least invasive way to mobilize stem cells while DDP4-inhibitor facilitates homing via stromal cell-derived factor 1 alpha (SDF-1α). Dutogliptin, a novel DPP4 inhibitor, combined with stem cell mobilization using G-CSF significantly improved survival and reduced infarct size in a murine model. Purpose We initiated a phase II, multicenter, randomized, placebo-controlled efficacy and safety study (N=140) analyzing the effect of combined application of G-CSF and dutogliptin, a small molecule DPP-IV-inhibitor for subcutaneous use after acute myocardial infarction. Methods The primary objective of the study is to evaluate the safety and tolerability of dutogliptin (14 days) in combination with filgrastim (5 days) in patients with STEMI (EF <45%) following percutaneous coronary intervention (PCI). Preliminary efficacy will be analyzed using cardiac magnetic resonance imaging (cMRI) to detect >3.8% improvement in left ventricular ejection fraction (LV-EF). 140 subjects will be randomized to filgrastim plus dutogliptin or matching placebos. Results Baseline characteristics of the first 26 patients randomized (24 treated) in this trial reveal a majority of male patients (70.8%) and a medium age of 58.4 years (37 to 84). During the 2-week active treatment period, 35 adverse events occurred in 13 patients, with 4 rated as serious (hospitalization due to pneumonia N=3, hospitalization due to acute myocardial infarction N=1), and 1 adverse event was rated as severe (fatal pneumonia), 9 moderate, and 25 as mild. 6 adverse events were considered possibly related to the study medication, including cases of increased hepatic enzymes (N=3), nausea (N=1), subcutaneous node/suffusion (N=1) and syncope (N=1). Conclusions Our data demonstrate that the combined application of dutogliptin and G-CSF appears to be safe on the short term and feasible after acute myocardial infarction and may represent a new therapeutic option in future. Funding Acknowledgement Type of funding source: Other. Main funding source(s): This research is funded by the sponsor RECARDIO, Inc., 1 Market Street San Francisco, CA 94150, USA. RECARDIO Inc. is funding the complete study. The Scientific Board of RECARDIO designed the study. Data Collection is at the participating sites. Interpretation of the data by the Scientific Board and Manuscript written by the authors and approved by the Sponsor

scholarly journals The effect of intracoronary infusion of bone marrow-derived mononuclear cells on all-cause mortality in acute myocardial infarction: the BAMI trial

2020 ◽  
Vol 41 (38) ◽  
pp. 3702-3710 ◽  
Author(s):  
Anthony Mathur ◽  
Francisco Fernández-Avilés ◽  
Jozef Bartunek ◽  
Ann Belmans ◽  
Filippo Crea ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Bone Marrow ◽  
Adverse Events ◽  
Left Ventricular ◽  
Phase Iii ◽  
Left Ventricular Ejection ◽  
Control Group ◽  
Intracoronary Infusion ◽  
All Cause Mortality

Abstract Aims  Bone marrow-derived mononuclear cell (BM-MNC) therapy may improve myocardial recovery in patients following acute myocardial infarction (AMI), though existing trial results are inconsistent. Methods and results  Originally an open-label, multicentre Phase III trial, BAMI was designed to demonstrate the safety and efficacy of intracoronary infusion of BM-MNCs in reducing the time to all-cause mortality in patients with reduced left ventricular ejection fraction (LVEF, ≤45%) after primary angioplasty (PPCI) for ST-elevation AMI. Unexpectedly low recruitment means the trial no longer qualifies as a hypothesis-testing trial, but is instead an observational study with no definitive conclusions possible from statistical analysis. In total, 375 patients were recruited: 185 patients were randomized to the treatment arm (intracoronary infusion of BM-MNCs 2–8 days after PPCI) and 190 patients to the control arm (optimal medical therapy). All-cause mortality at 2 years was 3.26% [6 deaths; 95% confidence interval (CI): 1.48–7.12%] in the BM-MNC group and 3.82% (7 deaths; 95% CI: 1.84–7.84%) in the control group. Five patients (2.7%, 95% CI: 1.0–5.9%) in the BM-MNC group and 15 patients (8.1%, CI : 4.7–12.5%) in the control group were hospitalized for heart failure during 2 years of follow-up. Neither adverse events nor serious adverse events differed between the two groups. There were no patients hospitalized for stroke in the control group and 4 (2.2%) patients hospitalized for stroke in the BM-MNC group. Conclusions  Although BAMI is the largest trial of autologous cell-based therapy in the treatment of AMI, unexpectedly low recruitment and event rates preclude any meaningful group comparisons and interpretation of the observed results.

scholarly journals Impact of Adiponectin and Leptin on Long-Term Adverse Events in Japanese Patients With Acute Myocardial Infarction

2013 ◽  
Vol 77 (11) ◽  
pp. 2778-2785 ◽  
Author(s):  
Yasuhiro Morita ◽  
Kengo Maeda ◽  
Takahisa Kondo ◽  
Hideki Ishii ◽  
Kyoko Matsudaira ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Adverse Events ◽  
Japanese Patients

Contribution of lipoprotein(a) to cardiovascular risk in patients under 40 years of age after acute myocardial infarction or acute cerebral circulation disorder

2016 ◽  
Vol 94 (3) ◽  
pp. 194-199 ◽  
Author(s):  
Viktoriya A. Korneva ◽  
T. Yu. Kuznetsova ◽  
A. S. Novitskaya ◽  
A. N. Malygin ◽  
T. A. Guseva ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Cardiovascular Risk ◽  
Arterial Hypertension ◽  
Cerebral Circulation ◽  
Age Groups ◽  
Middle Aged ◽  
Vascular Events ◽  
Lipoprotein A ◽  
Cerebral Circulation Disorders

Aim. To evaluate the importance of lipoprotein(a) for the evaluation of cardiovascular risk in patient under 40 years of age after acute myocardial infarction or acute cerebral circulation disorder. Materials and methods. We analysed the data from two departments of the Regional Vascular Centre for 2013-2015 including 90 case histories of patients of different age (mean 57.8±3.4 yr) and studied standard risk factors, such as age, sex, smoking habits, dyslipidemia, aggravated heredity, arterial hypertension (AH), obesity. Standard examination of 7 patients under 40 years of age was supplemented by measuring lipoprotein(a) by the immunoturbodimetric method regarding the levels over J. 3 g/l as abnormally elevated. Results. The study group was dominated by young and middle-aged men (85.2 and 84% respectively). The key riskfactors were increased LDLP level (88%) and smoking (70%) in patients under the age of 40 and AH in middle-aged men (100%, p<0.004). Arterial hypertension was also diagnosed in 59% of the younger subjects. Increased LDLP levels most frequently occurred in senior patients (90%). The group ofpatients under 40 yr included 15% of those having a single risk factor. In this group, 22% of the patients were at high risk calculated prior to the development of vascular events, 58% at moderate and 20% at low risk. 42.8% of the patients had elevated lipoprotein(a) levels. Conclusion. Based on the relative risk scoring scale, 22% of the patients under 40 years of age were at risk of myocardial infarction or cerebral circulation disorders prior to the development of vascular events. However, these patients like those of other age groups frequently had traditional riskfactors, such as smoking (67.5%), AH and dyslipidemia (66.6% each). Total cholesterol was elevated only in 47.6% of the patients while LDLP and LP(a) in 92 and 42.8% respectively.

scholarly journals Early Dynamic Change in High-Sensitivity Cardiac Troponin T in the Investigation of Acute Myocardial Infarction

2011 ◽  
Vol 57 (8) ◽  
pp. 1154-1160 ◽  
Author(s):  
Sally J Aldous ◽  
A Mark Richards ◽  
Louise Cullen ◽  
Martin P Than
Keyword(s):  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Adverse Events ◽  
Troponin T ◽  
Dynamic Change ◽  
High Sensitivity ◽  
Hazard Ratio ◽  
Diagnostic Sensitivity ◽  
Diagnostic Specificity ◽  
Coronary Syndrome

BACKGROUND The definition of acute myocardial infarction (AMI) requires a rise and/or fall in troponin with 1 or more results ≥99th percentile of the reference range. How much troponin must change has not been specified. We ascertained whether dynamic changes (δ) in high-sensitivity troponin T (hs-TnT) improved diagnostic and prognostic test performance in the emergency department. METHODS We recruited 939 patients with symptoms suggestive of acute coronary syndrome (without ST elevation). hs-cTnT was measured at 0 h and 2 h after presentation. End-points were admission diagnosis of AMI and 1-year adverse events (composite of death, AMI, revascularization). RESULTS Diagnostic specificity of 0–2-h hs-cTnT for AMI (incurred by 200 patients) improved from 79.8% (78.8%–80.5%) by using the 99th percentile alone to 94.2% (92.9%–95.4%) when we also included a δ ≥20%, but diagnostic sensitivity decreased from 94.5% (90.7%–96.9%) to 49.5% (44.6%–53.9%). With the inclusion of those patients with a δ ≥20% when 0–2-h hs-cTnT was &lt;99th percentile, in addition to any with concentrations ≥99th percentile, diagnostic sensitivity increased to 97.5% (94.4%–98.9%). hs-cTnT ≥99th percentile predicted adverse events (incurred by 111 patients), adjusted hazard ratio 1.9 (1.2–2.8), whereas a δ ≥20% did not, hazard ratio 1.1 (0.7–1.7). CONCLUSIONS Diagnostic specificity of hs-cTnT improved with the use of a δ ≥20% in those patients with concentrations ≥99th percentile, but at a cost of a large reduction in sensitivity. Diagnostic sensitivity improved with the use of a δ ≥20% in patients with 0–2-h concentrations &lt;99th percentile. Both approaches may be required for optimum rule-in and rule-out strategies, respectively. The δ criteria seem to be less useful for medium-term risk stratification.

Efficacy and Safety of Adjunctive Trimetazidine Therapy for Acute Myocardial Infarction: A Systematic Review and Meta-Analysis

Cardiology ◽  
2016 ◽  
Vol 135 (3) ◽  
pp. 188-195 ◽  
Author(s):  
Yongyong Li ◽  
Dewei Wang ◽  
Chunxiao Hu ◽  
Peng Zhang ◽  
Dongying Zhang ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Systematic Review ◽  
Acute Myocardial Infarction ◽  
Adverse Events ◽  
Meta Analysis ◽  
Efficacy And Safety ◽  
Short Term ◽  
All Cause Mortality ◽  
Acute Mi

Background: Several lines of evidence support the clinical use of trimetazidine as an adjunctive therapy in cardioischemic patients. Therefore, we assessed here the efficacy and safety of adjunctive trimetazidine therapy in acute myocardial infarction (MI) patients by a systematic review and meta-analysis of the current literature. Methods: PubMed, the Cochrane Library, and the China National Knowledge Infrastructure databases were searched for clinical studies comparing adjunctive trimetazidine therapy against placebo in adult acute MI patients. Several clinical outcomes [early/short-term all-cause mortality, long-term all-cause mortality, total major adverse cardiac events (MACE), recurrent nonfatal MI, in-hospital adverse events, target vessel revascularization (TVR), and coronary artery bypass graft (CABG)] were analyzed by the intention-to-treat principle. Odds ratios (OR) and their 95% confidence intervals (CI) were derived from the number of outcome events in each study arm to estimate the association between adjuvant trimetazidine administration and the various clinical outcomes. A random-effects model was applied for all meta-analyses. Results: We found that adjunctive trimetazidine therapy showed a significant effect upon total MACE (OR = 0.33, 95% CI = 0.15-0.74; p = 0.007) but showed no significant effect upon early/short-term all-cause mortality, long-term all-cause mortality, recurrent nonfatal MI, in-hospital adverse events, TVR, or CABG (p > 0.05). Conclusions: This is the first meta-analysis to report that adjunctive trimetazidine therapy has a beneficial effect upon total MACE in acute MI patients. Clinical investigators should consider further trials on adjunctive trimetazidine therapy in order to better define its risks and benefits in acute MI patients.

scholarly journals Oral treatment with nicorandil at discharge is associated with reduced mortality after acute myocardial infarction

2012 ◽  
Vol 59 (1) ◽  
pp. 14-21 ◽  
Author(s):  
Yasuhiko Sakata ◽  
Daisaku Nakatani ◽  
Masahiko Shimizu ◽  
Shinichiro Suna ◽  
Masaya Usami ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Oral Treatment

scholarly journals Clinical examples of microcirculation disorders in acute myocardial infarction

2016 ◽  
Vol 15 (1) ◽  
pp. 56-64
Author(s):  
K. A. Kireev ◽  
A. V. Krasnopeev
Keyword(s):  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Fatal Outcome ◽  
Reperfusion Therapy ◽  
Left Ventricular ◽  
Early Postoperative Period ◽  
St Segment Elevation ◽  
Coronary Syndrome ◽  
St Segment ◽  
Angiographic Result

Objective. To improve the results of acute myocardial infarction (AMI) treatment. Material and methods. We have analyzed 2 clinical cases of unfavorable course of AMI. Results. The middle aged patient who had ST segment elevation acute coronary syndrome received immediate full reperfusion therapy (thrombolysis and stenting). It was performed early in the course of the disease and demonstrated good angiographic result. Postoperatively there were no typical evolution of ECG signs of AMI. By the end of the first day we registered stent thrombosis with fatal outcome. Cause of death: acute left ventricular failure. The area of infarcted cardiac muscle was about 40 %, in the projection of the apex of the left ventricle the acute aneurysm was formed. Perhaps this situation has been associated with disorders of microcirculation in the infarcted area, which can be potentially neutralized by inhibitors 2b/3a receptors of platelets. This drug was given to this patient too late (during rethrombosis). In another observation (with the same circumstances) the inhibitor of IIb/IIIa GP receptors was given during the early postoperative period, what was followed by the natural course of AMI. Conclusion. These examples demonstrate the need of additional antiplatelet support (inhibitor IIb/IIIa GP receptors) in such clinical situations.

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