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The efficacy of intracoronary urokinase and streptokinase were compared in 80 patients with acute myocardial infarction in a prospective, randomized, double-blind study. Urokinase was infused into the occluded coronary artery at 6000 U/min, and streptokinase was infused at 2000 U/min. 756 MethodsThis was a randomized, double-blind, parallel study of the efficacy of intracoronary urokinase (Abbokinase; Abbott Pharmaceuticals) and streptokinase (Streptase; Hoechst-Roussel Pharmaceuticals, Inc.) in treating patients with acute myocardial infarction.Patients were eligible for inclusion in the study under the following conditions: (1) typical symptoms of myocardial infarction occurred less than 12 hr before infusion, (2) electrocardiogram showed short-term changes of myocardial infarction, (3) no specific contraindication to thrombolytic therapy existed, and (4) angiographic demonstration of a completely occluded vessel related to the infarct. After informed consent was obtained, the hospital pharmacy randomized the patient to receive either urokinase or streptokinase. Unlabeled thrombolytic solution, containing either streptokinase at a concentration of 500 IU/ml or urokinase at a concentration of 1500 U/ml, was supplied by the pharmacy. All medical personnel and the clinical investigators outside the pharmacy were blinded as to the thrombolytic drug used. Baseline coagulation studies before catheterization included measurements of serum fibrinogen, fibrin split products, thrombin time, prothrombin time, partial thromboplastin time, and plasminogen levels. In the catheterization laboratory, left ventricular and coronary angiography were performed. Heparin was given without knowledge of the treatment group in bolus doses ranging from 2500 U to 10,000 U. The thrombolytic solution was then infused into the occluded infarct-related vessel at a rate of 4 ml/min (

Implantation of a non-polymer based paclitaxel-elution stent and conventional ICR therapy for complex ISR lead to comparable acute and long-term clinical and angiographic follow-up results.

BackgroundCardiovascular diseases are the major cause of death globally and represent a major economic burden on health care systems. Positive effects of disease management programs have been shown for patients with heart failure (HF). Remote monitoring and telemonitoring with active intervention are beneficial in atrial fibrillation (AF) and therapy-resistant hypertension (TRH), respectively. For these patients, we have developed a novel integrated care concept (NICC) which combines telemedicine with intensive support by a care center, including a call center, an integrated care network including inpatient and outpatient care providers and guideline therapy for patients.MethodsThe aim of the study is to demonstrate the superiority of NICC over guideline therapy alone. The trial is designed as open-label, bi-center, parallel-group design with two groups and a blinded observer. Patients will be included if they are either inpatients or if they are referred to the outpatient clinic of the hospitals by their treating physician. Randomization will be done individually with stratification by cardiovascular disease (AF, HF, TRH), center and admission type. Primary endpoints are based on the 1-year observation period after randomization. The first primary endpoint is the composite endpoint consisting of mortality, stroke and myocardial infarction. The number of hospitalizations form the second primary endpoint. The third primary endpoint is identical to the first primary endpoint plus cardiac decompensation. Adjustments for multiple testing are done using a fall-back strategy. Secondary endpoints include patient adherence, health care costs, quality of life, and safety. A sample size of 2930 gives 80% power at the two-sided 2.5% test level for the first primary endpoint. The power for the second primary endpoint is 99.8% at this sample size, and it is 80% with 1086 patients.DiscussionThis study will inform care providers whether quality of care can be improved by an integrated care concept providing telemedicine through a round-the-clock call center approach. We expect that cost of the NICC will be lower than standard care because of reduced hospitalizations. If the study has a positive result, NICC is planned to be immediately rolled out in the federal state of Mecklenburg-West Pomerania and other federal states in Germany. The trial will also guide additional research to disentangle the effects of this complex intervention.Trial registrationDRKS, ID: DRKS00013124. Registered on 5 October 2017;ClinicalTrials.gov, ID: NCT03317951. Registered on 17 October 2017.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2502-1) contains supplementary material, which is available to authorized users.

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