Refractory AnginaPhase 2NCT04306237
A Study to Evaluate the Safety, Tolerability, and Efficacy of IMB-1018972 in Patients With Refractory Angina
A Phase 2 study testing IMB-1018972 in people with Refractory Angina, run by Imbria Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The objectives of the study are to assess the safety, tolerability, and potential efficacy of IMB-1018972 on patients with refractory angina. Study will assess functional capacity employing a modified Bruce Protocol treadmill ETT, patient reports of angina symptoms via an electronic diary, and activity using an… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Refractory Angina
- What is being tested?
- IMB-1018972
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2020to Apr 2025
- Phase
- Phase 2
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is between the ages of 18 and 85 years, inclusive.
- Is capable of understanding the written informed consent, and providing signed, dated, and witnessed written informed consent.
- Has complied with and is willing to continue to comply with the specified procedures (eg, angina diary during screening) and complete specific follow-up evaluations.
- Has coronary artery disease confirmed by at least one of the following:
- Documented prior MI, CABG surgery, or PCI -OR-
- Angiography performed within the 24 months prior to Visit 1 confirming CAD (eg, evidence of ≥70% stenosis of at least one major coronary artery or diffuse CAD).
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- Has evidence of stress induced ischemia documented by either:
- Protocol-specified ETT ECG demonstrating at least 0.5 mm exercise-induced ST segment depression with onset <9 minutes on at least 1 of the screening ETTs -OR-
- Prior evidence of stress-induced reversible perfusion defect in the last 24 months (without intervening revascularization) identified by at least one of the following:
- Radionuclide imaging study
- Echocardiographic imaging study
- FFR <0.8
- IFR <0.89
- FFR CT <0.8
- CFR <2.5
- Has a minimum 3 month history of exertional angina, including angina with a minimum frequency of 2 anginal episodes per week on average for the 2 weeks prior to enrolling in the study while on optimal guideline directed medical therapy for their angina.
- Is on optimal, dual agent, antianginal therapy for their angina for at least 1 month prior to the first screening ETT. Consistent with ACC/AHA and ESC Class I guideline directed medical therapy (GDMT), criteria for optimal therapy include treatment with both: (a) a beta-adrenergic blocking agent and treatment with (b) a calcium channel blocker OR a long-acting nitrate. If unacceptable side effects are intolerable and documented with a therapy listed in (a) or (b), treatment with only 1 antianginal medication is acceptable. Additionally, patients should be treated with short-acting nitrates per GDMT.
- Is currently not clinically indicated for coronary revascularization (ie, PCI or CABG) in the opinion of the principle investigator at the time of screening through 6 months after randomization.
- Has a CCS score of II, III or stabilized IV for 1 month prior to screening.
- Meets the following requirements after 2 screening modified Bruce protocol ETTs:
- Stopping the treadmill test due to angina on each test b. Total exercise duration must fall between 3 and 9 minutes on each test c. To document inducible myocardial ischemia: i. For those patients with interpretable ECGs, at least 0.5 mm exercise induced ST segment depression must occur with onset <9 minutes on at least 1 of the screening ETTs.
- Difference in TED between the 2 qualifying ETTs must not exceed 20% of the longer test or 1 minute, whichever limit is smaller.
- Consideration of a third ETT may be discussed by the investigator with the study medical monitor, who may authorize the performance of a third ETT a minimum of 5 days and no more than 10 days after the second ETT
Who cannot join
- If any of the following have occurred:
- Use of TMZ anytime in prior history
- In the prior 6 months:
- Diagnosis of NYHA Class 3 or 4 (heart failure)
- Hospitalization for heart failure
- Coronary artery bypass graft surgery
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- Cardiac resynchronization therapy placement or adjustments to CRT parameters
- Implantable cardioverter defibrillator or biventricular pacemaker placement
- In the prior 3 months:
- Hospitalization for a cardiovascular indication
- Cerebral vascular accident
- Transient ischemic attack
- Percutaneous coronary intervention
- In the prior 1 month:
- Use of perhexiline or meldonium.
- Has a history of moderate to severe valvular heart disease defined as aortic stenosis (valve area <1.5 cm2), aortic insufficiency, mitral stenosis (valve area <1.5 cm2), or mitral valve regurgitation of grade 3 or worse.
- Has significant hepatic disease, with increased liver function tests such as total bilirubin, aspartate aminotransferase, or alanine aminotransferase more than 2 times of ULN at baseline (excluding patients with documented history of Gilbert syndrome).
- Has severe renal impairment (ie, creatinine clearance <30 mL/min at screening, measured using 4-variable modification of diet in renal disease equation).
- Has a history of Parkinson disease, Parkinsonian symptoms, tremors, restless leg syndrome, or other related movement disorders.
- Has a history of vasospastic angina or microvascular angina.
- Has an exacerbating cause for angina (eg, anemia [ie, hemoglobin <10 g/dL], uncontrolled hypertension [ie, BP ≥160/90 mmHg], hyperthyroid, or rapid AF [ie, AF with average rate >120 beats per minute]) at screening.
- Has long-QT and life-threatening LV arrhythmia.
- Has comorbidities limiting life expectancy to less than 3 years.
- Is pregnant, planning pregnancy, or lactating.
- Has a history of alcohol abuse or drug addiction.
- Has a positive test for drugs (eg, opiates, methadone, cocaine, amphetamines [including ecstasy], or barbiturates) at screening.
- Has a positive test for HBsAg, HCV antibodies, or HIV1/2 antibodies at screening.
- Is participating in another research study.
- Is an employee or family member of the investigator or study site personnel.
Trial locations and contacts
1 site in 1 country.
United States1 site
Imbria Investigational Site
Boston, Massachusetts, 02110
About this study
Official title: A Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of IMB-1018972 in Patients With Refractory Angina
The objectives of the study are to assess the safety, tolerability, and potential efficacy of IMB-1018972 on patients with refractory angina. Study will assess functional capacity employing a modified Bruce Protocol treadmill ETT, patient reports of angina symptoms via an electronic diary, and activity using an accelerometer.
- Conditions
- Refractory Angina
- Being tested
- IMB-1018972, Placebo oral tablet
- Medical subject headings
- Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMB-1018972Drug
IMB-1018972 200 mg tablet for oral administration
Placebo oral tabletDrug
Matched placebo tablet for oral administration
| Study group | Role | What they receive |
|---|---|---|
| IMB-1018972 | Experimental | Participants will receive IMB-1018972 (200 mg) MR tablets twice daily for 16 weeks Receives: Drug: IMB-1018972 |
| Placebo | Placebo comparator | Participants will receive matching placebo tablets twice daily for 16 weeks Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Bruce Protocol Treadmill ETT
Change from baseline to Week 8 in total exercise duration (seconds)
Measured: 8 weeks
Safety and Tolerability of IMB-1018972 in Patients with Refractory Angina
Incidence of AEs, changes from baseline in physical examinations, vital signs, clinical laboratories, and ECG
Measured: 16 weeks
Secondary outcomes (3)
Assess the benefit of IMB-1018972 on patient report of angina symptoms employing an electronic diary
Change from baseline per week in the incidence of angina symptoms
Measured: 16 weeks
Assess the potential treatment benefit of IMB-1018972 on patient report of rescue NTG use employing an electronic diary
Change from baseline in daily counts of NTG use
Measured: 16 weeks
Assess the potential treatment benefit of IMB-1018972 on patient activity employing a wearable device
Change from baseline in total daily activity at Week 16 (activity units)
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start1 May 2020
- Primary completionFeb 2025 (estimated)
- Study completionApr 2025 (estimated)
Why it stopped: Coronavirus pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imbria Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Chamberlin, MD, Study director, Imbria Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04306237
- Sponsor's protocol ID
- CIMB-8972-201
- Status last verified
- Nov 2025
- First submitted
- 8 Mar 2020
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of IMB-1018972 in Patients With Refractory Angina
- ClinicalTrials.gov ID
- NCT04306237
- Acronym / sponsor ID
- CIMB-8972-201
- Conditions
- Refractory Angina
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Coronavirus pandemic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Imbria Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 May 2020 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 12 Mar 2020 (actual)
- 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.
The objectives of the study are to assess the safety, tolerability, and potential efficacy of IMB-1018972 on patients with refractory angina. Study will assess functional capacity employing a modified Bruce Protocol treadmill ETT, patient reports of angina symptoms via an electronic diary, and activity using an accelerometer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMB-1018972 | Experimental | Drug: IMB-1018972Participants will receive IMB-1018972 (200 mg) MR tablets twice daily for 16 weeks |
| Placebo | Placebo comparator | Drug: Placebo oral tabletParticipants will receive matching placebo tablets twice daily for 16 weeks |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Is between the ages of 18 and 85 years, inclusive.
- Is capable of understanding the written informed consent, and providing signed, dated, and witnessed written informed consent.
- Has complied with and is willing to continue to comply with the specified procedures (eg, angina diary during screening) and complete specific follow-up evaluations.
- Has coronary artery disease confirmed by at least one of the following:
- Has evidence of stress induced ischemia documented by either:
Key exclusion criteria (29 listed)
- If any of the following have occurred:
- Has a history of moderate to severe valvular heart disease defined as aortic stenosis (valve area <1.5 cm2), aortic insufficiency, mitral stenosis (valve area <1.5 cm2), or mitral valve regurgitation of grade 3 or worse.
- Has significant hepatic disease, with increased liver function tests such as total bilirubin, aspartate aminotransferase, or alanine aminotransferase more than 2 times of ULN at baseline (excluding patients with documented history of Gilbert syndrome).
- Has severe renal impairment (ie, creatinine clearance <30 mL/min at screening, measured using 4-variable modification of diet in renal disease equation).
- Has a history of Parkinson disease, Parkinsonian symptoms, tremors, restless leg syndrome, or other related movement disorders.
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 |
|---|---|---|
| IMB-1018972IMB-1018972 200 mg tablet for oral administration | Drug | IMB-1018972 |
| Placebo oral tabletMatched placebo tablet for oral administration | Drug | Placebo |
Primary outcome
Modified Bruce Protocol Treadmill ETT
Time frame: 8 weeks
Change from baseline to Week 8 in total exercise duration (seconds)
Safety and Tolerability of IMB-1018972 in Patients with Refractory Angina
Time frame: 16 weeks
Incidence of AEs, changes from baseline in physical examinations, vital signs, clinical laboratories, and ECG
3 secondary outcomes
Assess the benefit of IMB-1018972 on patient report of angina symptoms employing an electronic diary
Time frame: 16 weeks
Assess the potential treatment benefit of IMB-1018972 on patient report of rescue NTG use employing an electronic diary
Time frame: 16 weeks
Assess the potential treatment benefit of IMB-1018972 on patient activity employing a wearable device
Time frame: 16 weeks
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 10 Nov 2025.
- Individual participant dataSharing planned: No
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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.
Paul Chamberlin, MD study director
Imbria Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IMB-1018972 in people with Refractory Angina, run by Imbria Pharmaceuticals, Inc. at 1 site in United States.
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 23 inclusion and 29 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 10 Nov 2025. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Modified Bruce Protocol Treadmill ETT (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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 10 Nov 2025.