TRIAL OF CAFFEINE TO ALLEVIATE DYSPNEA RELATED TO TICAGRELOR(TROCADERO) A double-blinded, placebo-controlled, randomized, multicenter, development phase II study - TROCADERO

CR Uppsala Clinical Research Center0 个研究点目标入组 500 人开始时间: 2014年10月29日最近更新: 2015年12月14日

适应症

试验速览

暂无简介。

•Age = 18 years
•Acute coronary syndrome within the last 3 months with ongoing ticagrelor treatment
•Stabilized clinical condition with no plans of additional revascularization
•Dyspnea with onset after start of ticagrelor treatment
•Willingness to abstain from caffeine intake (e.g. coffee, tea, cola-type beverages and energy drinks; other foods, nutritional supplements or medications containing caffeine) for the duration of the study
•Provision of signed informed consent form
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 450
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

•Chronic obstructive pulmonary disease, asthma or other known pulmonary disease requiring daily medical therapy
•Obstructive sleep apnea syndrome requiring therapy
•Ongoing signs and symptoms of heart failure*, or evidence of moderately to severely reduced LV function
•Renal failure, GFR <30 or on dialysis
•Pregnancy or lactation
•Known allergy to ticagrelor, or caffeine, or known intolerance of caffeine.
•Ongoing treatment with any of the following: quinolone antibiotics, fluvoxamine, phenylpropanolamine, carbamazepine, clozapine, lithium, NSAIDs; or any drug containing theophylline or caffeine.
•Any condition that seriously increases the risk of non-compliance or loss of follow-up

发起方

CR Uppsala Clinical Research Center