Coronary VasospasmPhase 3NCT00454714
Therapeutic Effect of Sildenafil in Patients With Coronary Vasospasm
A Phase 3 study testing single dose Sildenafil in people with Coronary Vasospasm, run by Udo Sechtem at 1 site in Germany.
Trial summary
This will be a prospective, phase IIIb, double-blind and randomized trial testing the effect of single dose sildenafil application in patients with coronary vasospasm compared to placebo application. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Coronary Vasospasm
- What is being tested?
- single dose Sildenafil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2007to 31 Dec 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 50y
- Framingham risk score < 10%
- no contraindication to sildenafil application
- clinical history of atypical angina pectoris
- exclusion of significant coronary artery disease (stenosis ≥ 50%) by coronary angiography
- documented coronary spasm by ACh-testing in at least one coronary artery segment
- written informed consent
Who cannot join
- existing contraindication to sildenafil application
- significant coronary artery disease (≥ 50%)
- valvular, inflammatory, dilative or other cardiomyopathies
- congestive heart failure (left ventricular ejection fraction < 60%) of any reason
- need for therapeutic treatment with nitrates or intake of any nitrates in the last 24h before coronary angiography
- participation in another clinical trial at the moment or in the last 30 days
Show all 10Show fewer
- hypotonic blood pressure (<90/50mmHg)
- hepatic insufficiency (> Child-Pugh-classification A)
- renal insufficiency with a GFR < 60ml/min- pregnancy or lactation
- not able to consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application of Sildenafil in Patients With Documented Coronary Vasospasm to Explore the Pathophysiology of Coronary Vasospasm and the Therapeutic Effect of Sildenafil in Patients Suffering From Coronary Vasospasm
This will be a prospective, phase IIIb, double-blind and randomized trial testing the effect of single dose sildenafil application in patients with coronary vasospasm compared to placebo application.
The target variable to be tested is the degree of coronary vasoconstriction in response to intracoronary ACh application (in addition to clinical chest pain) which will be imaged by coronary angiography and measured using quantitative coronary angiography software.
Read more
Main objective: Has sildenafil the potency to inhibit the induction of coronary vasospasm by intracoronary ACh-application in patients with proven coronary artery spasm?
Secondary objective: Which degree of coronary vasospasm inhibition can be achieved with sildenafil?
Read the detailed description
Coronary artery spasm is an abrupt severe vasoconstrictor response which may occur spontaneously in normal and diseased coronary arteries. It may result in myocardial ischemia and may be provoked by various stimuli such as acetylcholine (ACh). Coronary vasospasm is involved in the pathogenesis of Prinzmetal's angina, acute myocardial infarction or sudden cardiac death due to ventricular arrythmias and chest pain symptoms associated with viral myocarditis.
The precise cellular and molecular mechanisms of coronary vasospasm have not yet been elucidated. The most often suggested but competing explanations for this disease are coronary endothelial dysfunction secondary to impaired nitric oxide production versus coronary smooth muscle cell hyperreactivity with or without additional endothelial dysfunction. As the precise cellular mechanism is currently unknown a large group of people can currently not be treated appropriately despite the use of nitrates and calcium antagonists.
Sildenafil is a phosphodiesterase(PDE)-5 inhibitor approved for the treatment of both erectile dysfunction and pulmonary hypertension. PDE-5 has been shown to be also present and play an important vasomotor role in the coronary vessel wall. Application of the inhibitor sildenafil has been shown to increase the resting coronary artery diameter. Furthermore, atherosclerotic coronary artery segments which vasoconstrict following intracoronary ACh-application vasodilate following the application of sildenafil when ACh-testing is repeated. Other studies are also suggesting an improved endothelial function after sildenafil application for both the coronary and the peripheral vasculature.
Taken together, sildenafil is expected to have a positive effect on coronary vasomotility. Whether sildenafil can totally prevent the occurrence of coronary vasospasm or at least decrease the severity of vasospasm has not been studied so far. Thus, the aim of this study is to analyse the possible anti-spastic effects of sildenafil in patients suffering from coronary vasospasm.
- Conditions
- Coronary Vasospasm
- Being tested
- single dose Sildenafil, Single dose placebo
- Medical subject headings
- Coronary Vasospasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single dose SildenafilDrug
Application of a single dose Sildenafil
Single dose placeboDrug
Application of a single dose placebo
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Sildenafil arm Receives: Drug: single dose Sildenafil |
| B | Placebo comparator | Placebo arm Receives: Drug: Single dose placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of coronary vasospasm in spite of medical treatment
Measured: After inclusion of last patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2007 (estimated)
- Study start1 Mar 2007
- Primary completion31 Dec 2009
- Study completion31 Dec 2009
Why it stopped: Study not started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary VasospasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Udo Sechtem
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Udo Sechtem, Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
- Investigators
- Udo Sechtem, MD, Study director, Robert Bosch-Krankenhaus Stuttgart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00454714
- Sponsor's protocol ID
- RBK091
- Status last verified
- Apr 2017
- First submitted
- 29 Mar 2007
- Last updated
- 12 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Sildenafil in Patients With Documented Coronary Vasospasm to Explore the Pathophysiology of Coronary Vasospasm and the Therapeutic Effect of Sildenafil in Patients Suffering From Coronary Vasospasm
- ClinicalTrials.gov ID
- NCT00454714
- Acronym / sponsor ID
- RBK091
- Conditions
- Coronary Vasospasm
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study not started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Udo SechtemUniversity, hospital or other
- Study start
- 1 Mar 2007
- Primary completion
- 31 Dec 2009 (actual)
- Study completion
- 31 Dec 2009 (actual)
- First posted
- 2 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a prospective, phase IIIb, double-blind and randomized trial testing the effect of single dose sildenafil application in patients with coronary vasospasm compared to placebo application.
The target variable to be tested is the degree of coronary vasoconstriction in response to intracoronary ACh application (in addition to clinical chest pain) which will be imaged by coronary angiography and measured using quantitative coronary angiography software.
Main objective: Has sildenafil the potency to inhibit the induction of coronary vasospasm by intracoronary ACh-application in patients with proven coronary artery spasm?
Secondary objective: Which degree of coronary vasospasm inhibition can be achieved with sildenafil?
Detailed description
Coronary artery spasm is an abrupt severe vasoconstrictor response which may occur spontaneously in normal and diseased coronary arteries. It may result in myocardial ischemia and may be provoked by various stimuli such as acetylcholine (ACh). Coronary vasospasm is involved in the pathogenesis of Prinzmetal's angina, acute myocardial infarction or sudden cardiac death due to ventricular arrythmias and chest pain symptoms associated with viral myocarditis.
The precise cellular and molecular mechanisms of coronary vasospasm have not yet been elucidated. The most often suggested but competing explanations for this disease are coronary endothelial dysfunction secondary to impaired nitric oxide production versus coronary smooth muscle cell hyperreactivity with or without additional endothelial dysfunction. As the precise cellular mechanism is currently unknown a large group of people can currently not be treated appropriately despite the use of nitrates and calcium antagonists.
Sildenafil is a phosphodiesterase(PDE)-5 inhibitor approved for the treatment of both erectile dysfunction and pulmonary hypertension. PDE-5 has been shown to be also present and play an important vasomotor role in the coronary vessel wall. Application of the inhibitor sildenafil has been shown to increase the resting coronary artery diameter. Furthermore, atherosclerotic coronary artery segments which vasoconstrict following intracoronary ACh-application vasodilate following the application of sildenafil when ACh-testing is repeated. Other studies are also suggesting an improved endothelial function after sildenafil application for both the coronary and the peripheral vasculature.
Taken together, sildenafil is expected to have a positive effect on coronary vasomotility. Whether sildenafil can totally prevent the occurrence of coronary vasospasm or at least decrease the severity of vasospasm has not been studied so far. Thus, the aim of this study is to analyse the possible anti-spastic effects of sildenafil in patients suffering from coronary vasospasm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: single dose SildenafilSildenafil arm |
| B | Placebo comparator | Drug: Single dose placeboPlacebo arm |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age ≥ 50y
- Framingham risk score < 10%
- no contraindication to sildenafil application
- clinical history of atypical angina pectoris
- exclusion of significant coronary artery disease (stenosis ≥ 50%) by coronary angiography
Key exclusion criteria (10 listed)
- existing contraindication to sildenafil application
- significant coronary artery disease (≥ 50%)
- valvular, inflammatory, dilative or other cardiomyopathies
- congestive heart failure (left ventricular ejection fraction < 60%) of any reason
- need for therapeutic treatment with nitrates or intake of any nitrates in the last 24h before coronary angiography
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| single dose SildenafilApplication of a single dose Sildenafil | Drug | A |
| Single dose placeboApplication of a single dose placebo | Drug | B |
Primary outcome
Incidence of coronary vasospasm in spite of medical treatment
Time frame: After inclusion of last patient
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
Related trials for Coronary Vasospasm
Active, not recruitingObservational study
The DISCOVER INOCA Prospective Multi-center Registry
Ischemia and No Obstructive Coronary Artery Disease, Coronary Microvascular Dysfunction
RecruitingObservational study
Coronary Microvascular Dysfunction Assessments in Myocardial Infarction With Non-Obstructive Coronary Arteries
Myocardial Infarction, Coronary Microvascular Dysfunction
Not yet recruiting
Comprehensive Invasive Physiological Evaluation of Obstructive Coronary Artery Disease
Coronary Artery Disease (CAD), Obstructive Coronary Artery Disease
Not yet recruiting
CompREhensive Diagnostic Assessment of Coronary Endothelial Function Impairment and Vasospasm With CoNtinuous ThErmodilution in Patients With Suspected Coronary Microvascular and Vasomotor Dysfunction
Coronary Microvascular Dysfunction (CMD), Vasospasm, Coronary
RecruitingObservational study
Mechanisms of Brain-Heart Injury of Post-Intracranial Hemorrhage
Subarachnoid Hemorrhage, Aneurysmal, Cerebrocardiac Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Udo Sechtem, MD study director
Robert Bosch-Krankenhaus Stuttgart
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing single dose Sildenafil in people with Coronary Vasospasm, run by Udo Sechtem at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of coronary vasospasm in spite of medical treatment (time frame: After inclusion of last patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2017.