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RESPONSIfVE: Efficacy and therapeutic response to Procoralan® in the treatment of chronic stable angina pectoris in routine medical practice
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ISRCTN
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ISRCTN73861224
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DOI
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10.1186/ISRCTN73861224
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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RESPONSIfVE: Efficacy and therapeutic response to Procoralan® in the treatment of chronic stable angina pectoris in routine medical practice
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Scientific title
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RESPONSIfVE: Efficacy and therapeutic response to Procoralan® in the treatment of chronic stable angina pectoris in routine medical practice – a prospective non-interventional study
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Acronym
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N/A
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Serial number at source
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IC4-16257-132-DEU
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Study hypothesis
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The study aims at gaining information on efficacy and tolerance of Procoralan® treatment (as proven in clinical trials) either in combination or not with beta blockers in patients under daily routine medical procedures.
Additional information is sought on the percentile distribution of patients who´s heart rate is reduced to less than 70 bpm or who´s heart rate is reduced by at least 10 bpm (responder analysis).
Supplementary information is to be gained regarding influence of Procoralan® therapy on angina pectoris symptoms and resting heart rate, on possible correlations between Procoralan® and various pre- and concomitant medications, on possible adverse drug reactions and on administration of Procoralan® in accordance to summary of product information and routine medical practice.
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Lay summary
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Lay summary under review 2
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Ethics approval
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Freiburg Ethics Commission International, January 14th, 2013
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Study design
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Multi-center prospective non-interventional study (post marketing authorisation)
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Countries of recruitment
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Germany
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Disease/condition/study domain
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Chronic stable angina pectoris / cardiology
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Participants - inclusion criteria
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1. Adult patients, either sex, with chronic stable angina pectoris
2. who are to be routinely treated with Procoralan®, regarding the summary of product characteristics, either in combination or not with beta blocker medications.
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Participants - exclusion criteria
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All contraindications listed in summary of product characteristics.
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Anticipated start date
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01/03/2013
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Anticipated end date
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30/09/2013
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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About 2000 patients in 500 centers
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Interventions
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The non-interventional study starts on March, 1st 2013 and ends on September, 30th 2013.
Patient recruitment will start on March, 1st 2013 with a time-frame of about three months. The individual observational period per patient will be about four months. The last patient may be enrolled into the study by May, 31st 2013. Dead-line for filled-in documents is October, 31st 2013.
Participating physicians receive a spiral folder including the complete documents for four patients with chronic stable angina pectoris who are to be treated routinely with Procoralan® . Data will be documented at four planed examinations. The exact dates are set according to routine medical procedure of the attending physician.
At baseline examination (U1; at the beginning of treatment) data will be documented on:
1. Date of examination
2. Patient data (age, gender, height, weight)
3. Anamnesis (duration and type of coronary heart disease, duration of chronic stable angina pectoris, CCS-classification, data on myocardial infarctions)
4. Further cardiac findings (chronic cardiac insufficiency, NYHA-classification, left-ventricular dysfunction, cardiac valvular defects) preceding therapies (PCI, CABG, cardiac pacemaker implantation )
5. Cardiovascular risk factors (genetic disposition, arterial hypertonia, diabetes mellitus, adiposity, dyslipidemia, nicotine abuse, elevated resting heart rate (>70 bpm)
6. Concomitant diseases (status post stroke, TIA, asthma, COPD, depression, sleep apnea, nephropathy, PVD, thyroid disease, other)
7. Use of beta blockers (current therapy, start of therapy, contraindications or intolerance to beta blockers such as asthma, hypotonia, arterioventricular conduction disturbances, bradycardia, COPD, erectile dysfunction, tiredness/fatigue, intake of calcium channel blockers (type verapamil/diltiazem), other), other cardiovascular medication (ACE-inhibitor, AT1-receptor antagonist, aldosterone antagonist, long-acting nitrates, ranolazine, molsidomine, calcium antagonists (type verapamil/diltiazem or dihydropyridine), NSAIDs, clopidogrel/prasugrel/ticagrelor, other platelet aggregation inhibitors, statine, diuretics, anti arrhythmic agents, other antilipemics)
8. Further concomitant medication (oral diabetics, insulin, anti depressants, oral anticoagulants, thyroxin, ulcer therapeutics, COPD-medication, medication for asthma, other medication)
9. Actual findings (heart rate, blood pressure, frequency of occurred angina pectoris episodes and usage of short-acting nitrates over the past seven days), Procoralan® therapy (patient classification, intended dose)
Data on examination 2 (U2, approximately one month following therapy start):
1. Date of examination
2. Information on continuation/discontinuation/change in dose of Procoralan® therapy
3. Information on possibly occurred adverse drug reactions or adverse reactions leading to termination of Procoralan® therapy
-information on changes in therapy with beta blockers or pharmaceutical treatment of stable angina pectoris
4. Actual findings (heart rate, blood pressure, frequency of occurred angina pectoris episodes and usage of short-acting nitrates over the past seven days)
Data on examination 3 (U3, approximately four months post start of therapy or at termination of Procoralan® therapy)
1. Date of examination
2. Information on continuation/discontinuation/change in dose of Procoralan® therapy
3. Information on possibly occurred adverse drug reactions or adverse reactions leading to termination of Procoralan® therapy
4. Information on changes in therapy with beta blockers or pharmaceutical treatment of stable angina pectoris
5. Actual findings (heart rate, blood pressure, frequency of occurred angina pectoris episodes and usage of short-acting nitrates over the past seven days, CCS-classification, NYHA-classification, left ventricular dysfunction)
6. Assessment of Procoralan® (efficacy, tolerance)
7. Possibly occurred particularities under Copaxone® (over dose, pregnancy)
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Primary outcome measure(s)
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The study aims at gaining information on efficacy and tolerance of Procoralan® treatment (as proven in clinical trials) either in combination or not with beta blockers in patients under daily routine medical procedures.
Additional information is sought on the percentil distribution of patients who´s heart rate is reduced to less than 70 bpm or who´s heart rate is reduced by at least 10 bpm (responder analysis).
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Secondary outcome measure(s)
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Supplementary information is to be gained regarding:
1. Influence of Procoralan® therapy on angina pectoris symptoms and resting heart rate
2. On possible correlations between Procoralan® and various pre- and concomitant medications
3. On possible adverse drug reactions
3. On administration of Procoralan® in accordance to summary of product information and routine medical practice
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Sources of funding
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Servier Deutschland GmbH (Germany)
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Trial website
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Publications
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Contact name
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Dr
Martin
Kühn
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Address
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Elsenheimer Str. 53
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City/town
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München
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Zip/Postcode
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80687
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Country
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Germany
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Sponsor
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Servier Deutschland GmbH (Germany)
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Address
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Elsenheimerstr. 53
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City/town
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München
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Zip/Postcode
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80687
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Country
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Germany
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Date applied
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24/01/2013
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Last edited
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15/02/2013
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Date ISRCTN assigned
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15/02/2013
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