Coronary Artery DiseasePhase 4IMAGENCT01755663
Comparison of Efficacy of Ivabradine Versus Metoprolol
A Phase 4 study testing Ivabradine and Metoprolol in people with Coronary Artery Disease, run by Col. Suthee Panichkul at 1 site in Thailand.
Trial summary
Ivabradine may be better than Metoprolol for controlling heart rate before Coronary CTA. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Ivabradine and Metoprolol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- Dec 2014to Dec 2015
- 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
- elective patient on scheduled for 640 slices CT coronary at Phramonkutklao hospital
- Resting heart rate > 70 BPM
- age > 18 years and informed consent
Who cannot join
- Heart rate > 100 BPM
- BP <100/60 mmHg
- recent congestive heart failure in 1 mo.
- SA node, AV node disease and AF
- on permanent pacemaker
- CrCL < 15ml/min. , AST or ALT > 3x UNL
- on HR reducing drug such as diltiazem, verapamil, digitalis
- contraindication for ivabradine or metoprolol
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Phramonkutklao Hospital
Bangkok, 10400
Purich Surunchupakorn, M.D., 081-988-7390, winnermd57@gmail.com
Purich - Surunchupakorn, M.D.
About this study
Official title: Comparison of Efficacy and Safety of Ivabradine Versus Metoprolol for Controlling Heart Rate Prior to 640-Slice Computed Tomographic Angiography in Elective Patients
Ivabradine may be better than Metoprolol for controlling heart rate before Coronary CTA.
- Conditions
- Coronary Artery Disease
- Being tested
- Ivabradine and Metoprolol
- Keywords
- CT coronary, Coronary arterial disease, ivabradine, metoprolol
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivabradine and MetoprololDrug
| Study group | Role | What they receive |
|---|---|---|
| Ivabradine | Experimental | Patients will recieved ivabradine(5) 1 tab bid pc for 3 day and the day of CT, and recieve placebo of metoprolol Receives: Drug: Ivabradine and Metoprolol |
| metoprolol | Active comparator | Metoprolol (100) 1/2 tab bid pc for 3 day and the day of CT coronary , and placebo of ivabradine Receives: Drug: Ivabradine and Metoprolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate of patient before CT coronary
Measured: 1 January 2013 to 31 december 2013
Secondary outcomes (1)
safety and side effect of Metoprolol and Ivabradine
Measured: 1 january 2013 to 31 december 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2012 (estimated)
- Study startDec 2014
- Primary completionDec 2014 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Col. Suthee Panichkul
- Sponsor type
- University, hospital or other
- Collaborators
- Phramongkutklao College of Medicine and Hospital
- Responsible party
- Sponsor-investigator, Col. Suthee Panichkul, Phramongkutklao College of Medicine and Hospital
- Investigators
- Purich - Surunchupakorn, M.D., Principal investigator, Phramongkutklao College of Medicine and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01755663
- Sponsor's protocol ID
- Pharmongkutklao
- Acronym
- IMAGE
- Status last verified
- Oct 2014
- First submitted
- 19 Dec 2012
- Last updated
- 29 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy and Safety of Ivabradine Versus Metoprolol for Controlling Heart Rate Prior to 640-Slice Computed Tomographic Angiography in Elective Patients
- ClinicalTrials.gov ID
- NCT01755663
- Acronym / sponsor ID
- IMAGE / Pharmongkutklao
- Conditions
- Coronary Artery Disease
- Keywords
- CT coronary, Coronary arterial disease, ivabradine, metoprolol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Col. Suthee PanichkulUniversity, hospital or other
- Collaborators
- Phramongkutklao College of Medicine and Hospital
- Study start
- Dec 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 24 Dec 2012 (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.
Ivabradine may be better than Metoprolol for controlling heart rate before Coronary CTA.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ivabradine | Experimental | Drug: Ivabradine and MetoprololPatients will recieved ivabradine(5) 1 tab bid pc for 3 day and the day of CT, and recieve placebo of metoprolol |
| metoprolol | Active comparator | Drug: Ivabradine and MetoprololMetoprolol (100) 1/2 tab bid pc for 3 day and the day of CT coronary , and placebo of ivabradine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- elective patient on scheduled for 640 slices CT coronary at Phramonkutklao hospital
- Resting heart rate > 70 BPM
- age > 18 years and informed consent
Key exclusion criteria (8 listed)
- Heart rate > 100 BPM
- BP <100/60 mmHg
- recent congestive heart failure in 1 mo.
- SA node, AV node disease and AF
- on permanent pacemaker
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 |
|---|---|---|
| Ivabradine and Metoprolol | Drug | Ivabradine, metoprolol |
Primary outcome
Heart rate of patient before CT coronary
Time frame: 1 January 2013 to 31 december 2013
1 secondary outcome
safety and side effect of Metoprolol and Ivabradine
Time frame: 1 january 2013 to 31 december 2013
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 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.
Purich - Surunchupakorn, M.D. principal investigator
Phramongkutklao College of Medicine and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ivabradine and Metoprolol in people with Coronary Artery Disease, run by Col. Suthee Panichkul at 1 site in Thailand.
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 3 inclusion and 8 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 29 Oct 2014. 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 Thailand. 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. 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 Purich Surunchupakorn, M.D. (081-988-7390, winnermd57@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate of patient before CT coronary (time frame: 1 January 2013 to 31 december 2013). 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 29 Oct 2014.