Vasospastic AnginaPhase 3STELLANCT02087007
A Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Cilostazol in Subjects With Vasospastic Angina
A Phase 3 study testing Cilostazol in people with Vasospastic Angina, run by Korea Otsuka Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
This study will be conducted in accordance with the local regulation of New Drug Application. Overall duration of this trial will be 3 years after approval of KFDA. Each subject will participate around 7 weeks, which include the 2 weeks Amlodipine run-in period, 4 weeks double blind period and 1 week safety follow up… Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Vasospastic Angina
- What is being tested?
- Cilostazol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2013to Jul 2015
- 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 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study :
- Male or female 20 or over the age of 20 and under the age of 80.
- Patients showing angina attack even while resting during the screening, diagnosed with vasospastic angina within the previous 3 months by meeting at least one of the 3 definitions, and accompanying insignificant (stenosis rate <50%) coronary artery disease documented by coronary angiography within the last 3 months [temporary antispastic agents (monotherapies or a combination of Verapamil and Nitroglycerin, anticoagulants) for coronary angiography are allowed]
- Chest pain accompanied by at least 2 temporary, closely located ST elevations or depressions of 0.1mV or greater in the absence of ergonovine provoked coronary angiography.
- Positive Intracoronary (IC) or Intravenous (IV) Ergonovine provocation test; ischemic ECG change accompanied by chest pain and spasm reducing the coronary diameter by 90% or more (at least 2 temporary, closely located ST elevations or depressions of 0.1mV or greater on 12-lead ECG)
- Patients who reported at least 1 episode of chest pain in a week during amlodipine run-in period and at least 2 episodes in the final week.
- Women who had been menopausal or sterile for at least 1 year, or women of childbearing potential who agree to practice a contraceptive measure throughout the clinical trial (e.g., hormonal contraceptives, intrauterine devices, condom + spermicidal agents, diaphragm + spermicidal agents, and partner's infertility)
- Subjects who signed a written agreement indicating that they were given full explanations of the clinical trial and are willing to participate in the clinical trial.
Subjects presenting with any of the following will not be included in the study:
- Subjects who used Cilostazol within 3 months before the screening visit
- Subjects who used antiplatelet drugs, including Aspirin, Clopidogrel, Ticlopidine and Sarpogrelate, or PDE3 inhibitors of the same class as Cilostazol, such as Amrinone, Milrinone and Enoximone, after the initiation of the amlodipine run-in period
- Subjects who used oral anticoagulants, such as warfarin, within 1 months prior to the screening visit
- Subjects who used any of the following drugs within 1 week prior to the screening visit
- CCBs apart from amlodipine
- Beta-blockers or alpha-blockers
- Oral nitrate, excluding nitroglycerin sublingual tablet, Nicorandil
- Vitamin E preparations
- Estrogens
- History of myocardial infarction or with myocardial infarction mediated by vasospastic angina at the time of screening
- History of a life-threatening vasospastic event (e.g., ventricular tachycardia, atrial fibrillation or syncope)
- History of stroke, intracranial hemorrhage or transient ischemic attack (TIA)
- Hemorrhage (hemophilia, capillary fragility, upper gastrointestinal bleeding, urinary tract bleeding, hemoptysis, vitreous hemorrhage, etc.) or such predisposition (active peptic ulcer, hemorrhage suspected at Cilostazol administration for surgical wound within the last 3 months, proliferative diabetic retinopathy)
- History of hypersensitivity to the ingredients of Cilostazol, amlodipine, dihydropyridines such as nitroglycerine, and nitrates
- Severe aortic stenosis
- History of shock
- Hypotension with systolic pressure of below 90mmHg at screening
- Severe anemia with hemoglobin 6.5g/dl or below at screening
- History of glaucoma
- ST change abnormality not interpretable on ECG at screening
- Congestive heart failure with left ventricular ejection fraction <40% on echocardiography at screening or within the last 3 months
- Atrial fibrillation or beyond moderate valvular heart disease
- Left main coronary spasm suspected or confirmed by coronary angiography or ergonovine provoked coronary angiography
- History of coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI)
- Heart rate >100 bpm at screening via vital sign: tachycardia
- Uncontrolled hypertension with systolic pressure ≥ 160 mmHg or diastolic pressure ≥ 100 mmHg at screening
- Creatinine level ≥ 1.5 mg/dL at screening
- AST or ALT > x3 ULN(Upper Limit of Normal) at screening
- Platelet count < 100,000mm3 at screening
- QT prolongation of QTcB > 450 msec in male and QTcB>470 msec in female subjects at screening
- Women of childbearing potential with positive pregnancy test at screening
- Women who did not agree to practice a contraceptive measure, pregnant or lactating women
- Drug compliance of less than 80% during 2-week amlodipine run-in period
- Subjects otherwise judged by the investigator to be inappropriate for inclusion in the trial
- Subjects who used another investigational products within 2 months prior to the randomization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Pletaal(Cilostazol) in Subjects With Vasospastic Angina
This study will be conducted in accordance with the local regulation of New Drug Application. Overall duration of this trial will be 3 years after approval of KFDA.
Each subject will participate around 7 weeks, which include the 2 weeks Amlodipine run-in period, 4 weeks double blind period and 1 week safety follow up period
Read the detailed description
A Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel group, Therapeutic confirmatory Study.
The subject who has at least one episode of chest pain weekly and at least two episodes of chest pain during last week despite Amlodipine 5mg qd taking during 2 weeks will have treatment of Pletaal(Cilostazol) or Placebo for 4 weeks. Pletaal(Cilostazol) is taken 100mg oral tablets bid during 2 weeks after dosing of Pletaal(Cilostazol) 50mg oral tablets bid during 2 weeks. Placebo of Pletaal(Cilostazol) is used as the control medication.
- Conditions
- Vasospastic Angina
- Being tested
- Cilostazol, placebo
- Keywords
- Treatment for vasospastic angina
- Medical subject headings
- Angina Pectoris, Variant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CilostazolDrug
100mg oral tablets bid during 2 weeks after dosing of 50mg oral tablets bid during 2 weeks
placeboDrug
100mg oral placebo tablets bid during 2 weeks after dosing of 50mg oral placebo tablets bid during 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | Cilostazol 50mg, Cilostzaol 100mg Receives: Drug: Cilostazol |
| group 2 | Placebo comparator | placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chest Pain Frequency
Change of the chest pain frequency on the final a week after IP dosing from a week before IP dosing
Measured: Baseline and Week 4
Secondary outcomes (5)
Percent change of the chest pain frequency
Percent change of the chest pain frequency on the final a week after IP dosing from a week before IP dosing
Measured: Baseline and Week 4
Proportion of subjects without chest pain
Proportion of subjects without chest pain on the final a week after IP dosing
Measured: 4 weeks
total chest pain intensity
Change of the total pain intensity on the final a week after IP dosing from a week before IP dosing
Measured: Baseline and Week 4
average pain intensity(the total pain intensity/the number of pain)
Change of the average pain intensity(the total pain intensity/the number of pain) on the final a week after IP dosing from a week before IP dosing
Measured: Baseline and Week 4
total nitroglycerin sublingual consumption
Change of the total nitroglycerin sublingual consumption of the final a week after IP dosing from a week before IP dosing
Measured: Baseline and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startNov 2013
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vasospastic AnginaStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02087007
- Sponsor's protocol ID
- 021-KOA-1301i
- Acronym
- STELLA
- Status last verified
- May 2017
- First submitted
- 17 Feb 2014
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Pletaal(Cilostazol) in Subjects With Vasospastic Angina
- ClinicalTrials.gov ID
- NCT02087007
- Acronym / sponsor ID
- STELLA / 021-KOA-1301i
- Conditions
- Vasospastic Angina
- Keywords
- Treatment for vasospastic angina
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 14 Mar 2014 (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 study will be conducted in accordance with the local regulation of New Drug Application. Overall duration of this trial will be 3 years after approval of KFDA.
Each subject will participate around 7 weeks, which include the 2 weeks Amlodipine run-in period, 4 weeks double blind period and 1 week safety follow up period
Detailed description
A Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel group, Therapeutic confirmatory Study.
The subject who has at least one episode of chest pain weekly and at least two episodes of chest pain during last week despite Amlodipine 5mg qd taking during 2 weeks will have treatment of Pletaal(Cilostazol) or Placebo for 4 weeks. Pletaal(Cilostazol) is taken 100mg oral tablets bid during 2 weeks after dosing of Pletaal(Cilostazol) 50mg oral tablets bid during 2 weeks. Placebo of Pletaal(Cilostazol) is used as the control medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Drug: CilostazolCilostazol 50mg, Cilostzaol 100mg |
| group 2 | Placebo comparator | Drug: placeboplacebo |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Cilostazol100mg oral tablets bid during 2 weeks after dosing of 50mg oral tablets bid during 2 weeks | Drug | group 1 |
| placebo100mg oral placebo tablets bid during 2 weeks after dosing of 50mg oral placebo tablets bid during 2 weeks | Drug | group 2 |
Primary outcome
Chest Pain Frequency
Time frame: Baseline and Week 4
Change of the chest pain frequency on the final a week after IP dosing from a week before IP dosing
5 secondary outcomes
Percent change of the chest pain frequency
Time frame: Baseline and Week 4
Proportion of subjects without chest pain
Time frame: 4 weeks
total chest pain intensity
Time frame: Baseline and Week 4
average pain intensity(the total pain intensity/the number of pain)
Time frame: Baseline and Week 4
total nitroglycerin sublingual consumption
Time frame: Baseline and Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
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Implantable Cardioverter Defibrillator Versus Optimal Medical Therapy In Patients With Variant Angina Manifesting as Aborted Sudden Cardiac Death
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iCorMicA - Stratified Medicine in Angina
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Active, not recruiting
Cardioneuroablation for Variant Angina
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cilostazol in people with Vasospastic Angina, run by Korea Otsuka Pharmaceutical Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 4 May 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 South Korea. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Chest Pain Frequency (time frame: Baseline and Week 4). 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 4 May 2017.