Effect of 8 weeks oral pentaerithrityltetranitrate on endothelial dysfunction in patients with coronary artery disease: a prospective, randomized, double-blind, placebo-controlled, monocentric clinical trial of phase IV

ISRCTN ISRCTN14741769
DOI https://doi.org/10.1186/ISRCTN14741769
EudraCT/CTIS number 2006-004533-15
Secondary identifying numbers N/A
Submission date
29/05/2007
Registration date
07/06/2007
Last edited
07/01/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Ascan Warnholtz
Scientific

Langenbeckstr. 1
Mainz
55131
Germany

Study information

Study designA prospective, placebo-controlled, double-blind, randomized, parallel group, single center, two-armed, clinical trial of phase IV
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleEffect of 8 weeks oral pentaerithrityltetranitrate on endothelial dysfunction in patients with coronary artery disease: a prospective, randomized, double-blind, placebo-controlled, monocentric clinical trial of phase IV
Study acronymPENTA
Study objectivesEight weeks of oral pentaerithrithyltetranitrate therapy in addition to standard long-term Coronary Artery Disease (CAD) medication improves flow dependent vasodilation (FMD) in patients suffering from CAD.
Ethics approval(s)Ethics committee of the physicians chamber of Rhineland-Palatinate (Ethik-Kommission der Landesärztekammer Rheinland-Pfalz), approved on 21.03.2007.
Health condition(s) or problem(s) studiedCoronary artery disease
InterventionEight weeks of pentaerithrityltetranitrate, 80 mg, 3 x orally per day.
Intervention typeDrug
Pharmaceutical study type(s)
PhasePhase IV
Drug / device / biological / vaccine name(s)pentaerithrithyl tetranitrate
Primary outcome measureFMD at baseline and after 8 weeks of treatment, measured by high-resolution ultrasound of the right brachial artery diameter percentage change upon reactive hyperemia after 5 minutes suprasystolic occlusion of the upper arm.
Secondary outcome measuresThe following will also be assessed at baseline and after 8 weeks of treatment:
1. Cardiovascular biomarkers (high-sensitivity C-Reactive Protein [hs-CRP], lipid profile, ferritin, bilirubin, uric acid)
2. Endothelium-independent nitrogylcerin-induced vasodilation (NMD)
3. Endo-PAT2000 (device for assessing endothelial function) reactive hyperemia index
Overall study start date01/06/2007
Completion date31/05/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants80 subjects, 40 per treatment group
Total final enrolment80
Key inclusion criteria1. Men or women > 35 and < 80 years of age
2. Documented clinically stable CAD with stable angina pectoris
3. Ability of subject to understand the character and individual consequences of the clinical trial
4. Written informed consent must be available before enrollment in the trial
5. For women with childbearing potential, adequate contraception (oral contraceptives or intrauterine devices) is required
Key exclusion criteria1. Clinical signs of congestive heart failure or left ventricular ejection fraction <30% (as demonstrated within the last 1 year by echocardiography, Left Ventricular [LV] angiography, Magnetic Resonance Imaging [MRI] or radionuclide ventriculography, respectively)
2. Uncontrolled hypertension (blood pressure >180/110mmHg) or hypotension (systolic blood pressure <110 mmHg)
3. Initiation of any of the following medications within the last 8 weeks: aspirin, statins, calcium antagonists, Angiotensin Converting Enzyme (ACE)-inhibitors or AT1 receptor blockers, hormone replacement therapy. Individuals who take any of these drugs longer than 8 weeks can be included in this trial.
4. Use of Phosphodiesterase-5-inhibitors (Viagra®, Revatio®, Cialis®, Levitra®), dihydroergotamine and nitrates i.e. isosorbidemononitrate, isosorbidedinitrate, nitroglycerin, pentaerithrityltetranitrate or molsidomin within the last two weeks.
5. Hemodynamically significant aortic or mitral stenosis or hypertrophic obstructive cardiomyopathy (as demonstrated within the last year by echocardiography, invasive right/ left heart catherterization or MRI, respectively)
6. Renal dysfunction (plasma creatinine [men: > 2.0 mg/dl, women: > 1.8 mg/dl])
7. Known hepatic disease or elevation of serum transaminases or gGT > 3 x Upper Limit of Normal range (ULN)
8. White Blood Cells (WBC) >16.000 or platelet count >500.000/µl or <75.000/µl
9. Clinically overt hyperthyreodism
10. Pregnancy and lactation
11. Known intolerance to organic nitrates
12. Known lactose intolerance
13. History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product
14. Other significant laboratory abnormalities that the investigator feels may compromise the patient's safety by participation in the study
15. In other clinical trials and observation period of competing trials, respectively
Date of first enrolment01/06/2007
Date of final enrolment31/05/2008

Locations

Countries of recruitment

  • Germany

Study participating centre

Langenbeckstr. 1
Mainz
55131
Germany

Sponsor information

Johannes Gutenberg University of Mainz (Germany)
University/education

Langenbeckstr. 1
Mainz
55131
Germany

Website http://www.uni-mainz.de/eng/
ROR logo "ROR" https://ror.org/023b0x485

Funders

Funder type

Industry

Actavis Germamy GmbH & Co KG (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/02/2010 07/01/2020 Yes No

Editorial Notes

07/01/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The EudraCT number has been added.