Microvascular AnginaPhase 4NCT02284048
Effect of Ticagrelor on Adenosine-Induced Coronary Flow Reserve in Patients With Microvascular Angina
A Phase 4 study testing ticagrelor in people with Microvascular Angina, run by Second Xiangya Hospital of Central South University.
Trial summary
This study is undertaken to determine if ticagrelor augments adenosine-induced coronary flow reserve (CFR), ameliorates clinical symptomatology and exercise tolerance in patients with MVA Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Microvascular Angina
- What is being tested?
- ticagrelor
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Nov 2017
- Phase
- Phase 4
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For inclusion in the study subjects should fulfill the following criteria:
- Provision of informed consent prior to any study specific procedures
- Female or male aged 18-80 years
- A diagnosis of stable primary MVA based on the presence of
- a history of typical effort angina,
- exercise-induced ST-segment depression>1 mm,
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- normal or near-normal (coronary artery stenosis<50%) coronary angiography,
- absence vasospastic angina
- a coronary flow reserve (CFR) <2.5 in the left anterior descending coronary artery as assessed by coronary blood flow (CBF) response to adenosine at transthoracic Doppler echocardiography
- suboptimal control of symptoms on conventional anti-ischemic therapy, as indicated by the occurrence of >1 episode per week of angina
Who cannot join
- ubjects should not enter the study if any of the following exclusion criteria are fulfilled:
- concomitance with any of the cardiac condition below
- significant （>50%）coronary plaque disease
- coronary artery spasm at angiography or other evidence of vasospastic angina
- valvular or other structural heart disease
- uncontrolled hypertension
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- abnormal echocardiographic examination including left ventricular hypertrophy
- no previous consumption of the ticagrelor
- no apparent contraindications to ticagrelor administration.
- History of Intracranial Hemorrhage
- Active Bleeding
- Severe Hepatic Impairment: AST and ALT are greater than 3 times of the upper limit. Bilirubin is greater than the upper limit.
- hypersensitivity (e.g. angioedema) to ticagrelor or any component of the product
- severe COPD or asthma
Trial locations and contacts
No sites are listed yet.
About this study
This study is undertaken to determine if ticagrelor augments adenosine-induced coronary flow reserve (CFR), ameliorates clinical symptomatology and exercise tolerance in patients with MVA
Read the detailed description
Considering the reduced CFR and increased platelet aggregability in patients with MVA, together with the augmented effect on adenosine-mediated coronary blood flow and potent antiplatelet effect of ticagrelor, we speculate that ticagrelor can promisingly ameliorate the coronary microvascular function in patients with MVA.
- Conditions
- Microvascular Angina
- Being tested
- ticagrelor
- Keywords
- Ticagrelor, Coronary Flow Reserve
- Medical subject headings
- Microvascular Angina
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ticagrelorDrug
Also called Brilinta
compare the effect of ticagrelor and control on the Coronary Flow Reserve in patients with microvessel angian
| Study group | Role | What they receive |
|---|---|---|
| control | Placebo comparator | nitrate,beta blocker Receives: Drug: ticagrelor |
| ticagrelor | Active comparator | ticagrelor 90mg qd Receives: Drug: ticagrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
adenosine-induced coronary flow reserve (CFR)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2016 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microvascular AnginaStudies of the same condition, open and under way.
- More trials run by Second Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daoquan Peng, Second Xiangya Hospital of Central South University
- Investigators
- Daoquan Peng, MD, PhD, Study chair, Second Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02284048
- Sponsor's protocol ID
- ISSBRIL0217
- Status last verified
- Nov 2014
- First submitted
- 2 Nov 2014
- Last updated
- 6 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ticagrelor on Adenosine-Induced Coronary Flow Reserve in Patients With Microvascular Angina
- ClinicalTrials.gov ID
- NCT02284048
- Acronym / sponsor ID
- ISSBRIL0217
- Conditions
- Microvascular Angina
- Keywords
- Ticagrelor, Coronary Flow Reserve
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Second Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 5 Nov 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 is undertaken to determine if ticagrelor augments adenosine-induced coronary flow reserve (CFR), ameliorates clinical symptomatology and exercise tolerance in patients with MVA
Detailed description
Considering the reduced CFR and increased platelet aggregability in patients with MVA, together with the augmented effect on adenosine-mediated coronary blood flow and potent antiplatelet effect of ticagrelor, we speculate that ticagrelor can promisingly ameliorate the coronary microvascular function in patients with MVA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Placebo comparator | Drug: ticagrelornitrate,beta blocker |
| ticagrelor | Active comparator | Drug: ticagrelorticagrelor 90mg qd |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Provision of informed consent prior to any study specific procedures
- Female or male aged 18-80 years
- A diagnosis of stable primary MVA based on the presence of
Key exclusion criteria (14 listed)
- ubjects should not enter the study if any of the following exclusion criteria are fulfilled:
- concomitance with any of the cardiac condition below
- no previous consumption of the ticagrelor
- no apparent contraindications to ticagrelor administration.
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 |
|---|---|---|
| ticagrelorAlso: Brilintacompare the effect of ticagrelor and control on the Coronary Flow Reserve in patients with microvessel angian | Drug | control, ticagrelor |
Primary outcome
adenosine-induced coronary flow reserve (CFR)
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2014.
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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.
Daoquan Peng, MD, PhD study chair
Second Xiangya Hospital of Central South University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ticagrelor in people with Microvascular Angina, run by Second Xiangya Hospital of Central South University.
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 10 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 6 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daoquan Peng, MD, PhD (86-731-85295806, pengdq@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adenosine-induced coronary flow reserve (CFR) (time frame: 2 months). 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 6 Nov 2014.