Temanogrel for Microvascular Obstruction (MVO)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Palo Alto Veterans Affair Medical Center, Palo Alto, CA
Microvascular Obstruction (MVO)
Temanogrel - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug called temanogrel can improve blood flow in people with heart disease.

See full description

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Microvascular Obstruction (MVO)

Study Objectives

This trial is evaluating whether Temanogrel will improve 2 primary outcomes and 6 secondary outcomes in patients with Microvascular Obstruction (MVO). Measurement will happen over the course of Baseline (prior to administration of study treatment) to Post-PCI on Day 1.

Hour 24
Incidence of Procedural Myocardial Injury
Day 1
Change From Baseline to Post-PCI for Angiographic Measures
Change From Baseline to Post-PCI for Myocardial Injury Markers
Change From Baseline to Post-PCI for Other Coronary Physiology Indices
Change in Index of Microcirculatory Resistance (IMR) From Baseline to Post-PCI
Change in Index of Microcirculatory Resistance (IMR) From Baseline to Post-Percutaneous Coronary Intervention (PCI)
Hour 24
Observed Maximum Plasma Concentration (Cmax) of Temanogrel and Active Metabolites AR295980 and AR295981
Day 8
Number and Severity of Adverse Events

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Microvascular Obstruction (MVO)

Trial Design

3 Treatment Groups

Stage A (Dose Cohort 2) and Stage B (Dose Group 2)
1 of 3
Stage A (Dose Cohort 1) and Stage B (Dose Group 1)
1 of 3
Stage A (Dose Cohort 1 and Dose Cohort 2) and Stage B (Dose Group 1 and Dose Gro...
1 of 3
Experimental Treatment
Non-Treatment Group

This trial requires 99 total participants across 3 different treatment groups

This trial involves 3 different treatments. Temanogrel is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Stage A (Dose Cohort 2) and Stage B (Dose Group 2)
Drug
Stage A (Dose Cohort 1) and Stage B (Dose Group 1)
Drug
Stage A (Dose Cohort 1 and Dose Cohort 2) and Stage B (Dose Group 1 and Dose Group 2)
Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline (prior to administration of study treatment); pre-pci; and at 1, 3, 6 and 24 hours post-pci
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline (prior to administration of study treatment); pre-pci; and at 1, 3, 6 and 24 hours post-pci for reporting.

Closest Location

Palo Alto Veterans Affair Medical Center - Palo Alto, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Stable angina participants suitable for elective PCI, or participants suitable for PCI for diagnosis of non-ST-elevation myocardial infarction or unstable angina (NSTEMI/UA) who are consistently hemodynamically stable until the time of PCI and have a thrombolysis in myocardial infarction (TIMI) Flow Grade 2 or 3 on the diagnostic angiography
Target lesions for PCI must appear suitable for stenting as confirmed on the diagnostic angiography and must satisfy the study criteria regarding lesion size and vessel diameter/type.
Females must not be of childbearing potential
You are male and have a female partner of childbearing potential. show original

Patient Q&A Section

What is microvascular obstruction (mvo)?

"The mvo is a rare finding in the kidney. More detailed studies are needed to define the pathophysiology, clinical significance and differential diagnosis of mvo in the kidney." - Anonymous Online Contributor

Unverified Answer

What causes microvascular obstruction (mvo)?

"It is probable that mvo causes more damage to the organ than blood loss and is, therefore, an important risk factor for acute kidney injury (AKI) after cardiac surgery." - Anonymous Online Contributor

Unverified Answer

What are common treatments for microvascular obstruction (mvo)?

"Microvascular obstruction (MVO) of the brain, also known as microinfarction, has a variety of causes. In addition, MVO can result in a wide range of symptoms, including headaches, visual changes, and changes in mood. Tissue plasminogen activator (tPA) infusion, intravenous rtPA, and intra-arterial thrombolysis with a microcatheter and microinfusion pump are common treatments for MVO. However, because many of the symptoms depend on the severity of MVO and the patient's preexisting health, it is often difficult to attribute specific symptoms to MVO treatment versus other causes." - Anonymous Online Contributor

Unverified Answer

Can microvascular obstruction (mvo) be cured?

"Many children with mvo demonstrated marked deterioration in their hemodynamics or function over a mean period of 6 yr despite ongoing medical treatment. At midterm follow-up these deteriorations remained more pronounced, with additional deterioration in the cerebral microcirculation. We conclude that the resolution of MVO following endovascular treatment does not necessarily mean clinical remission." - Anonymous Online Contributor

Unverified Answer

How many people get microvascular obstruction (mvo) a year in the United States?

"The rate of mvo in the US is 0.45 per 100,000 population per year. This translates to 0.14 percent of men and women in the country." - Anonymous Online Contributor

Unverified Answer

What are the signs of microvascular obstruction (mvo)?

"We did not identify significant difference in the prevalence of acute ischemic lesions between patients with and without microvascular obstruction. However, the findings of the present study demonstrated that both patients with and without macrothrombi had more hemorrhagic lesions than patients without acute ischemic lesions. Patients with microthrombi may need special attention to hemorrhagic manifestations and microvascular patency. Furthermore, evaluation of the severity of these lesions may be useful in predicting the severity of stroke and outcome." - Anonymous Online Contributor

Unverified Answer

Is temanogrel safe for people?

"When prescribing the antiplatelet agents as part of the secondary prophylaxis after THA/TKA, our study showed that, when compared with other studies, a less frequent, more brief hospital stay and the early discontinuation of one of the antiplatelet agents may be important to consider." - Anonymous Online Contributor

Unverified Answer

Does microvascular obstruction (mvo) run in families?

"We found evidence for an over-representation of MVO in families of children with RPAI. This may be explained with the common occurrence of RPAI and MVO in the first degree relatives of the children with RPAI. Given the high prevalence of MVO in RPAI, it must be addressed in future families with RPAI." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for microvascular obstruction (mvo)?

"Microvascular obstruction in a patent ductus arteriosus (PDA) represents an extremely rare occurrence (<1%). Therefore, the overall incidence of this complication is not known. The treatment of choice was open correction of vascular obstruction with excision of the ductus arteriosus in patients at higher risk of complications during operative time, postoperatively and at long-term follow-up. Survival of these patients was improved when they entered a clinical trial (P = 0.016) and there was a significant (P < 0.001) improvement in their functional status at long-term compared to patients who received nonoperative treatment and did not enter a clinical trial (P = 0.056)." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of microvascular obstruction (mvo)?

"MVO is typically the result of a number of factors, including the following. Primary etiologies include thromboembolic events, myocardial infarction, and arterial stenosis. Secondary etiologies include atrial fibrillation, hypertension, cardiac valve disorders, systemic emboli, thrombophilia states, vascular diseases, tumors, infiltrates, infiltrates or abscess, and amyloidosis. Other causes not mentioned can occur, such as atherosclerosis, and hyperglycemia. MVO also can be caused by the obstruction of coronary vessels and systemic thromboemboli. A specific etiology can be demonstrated in less than 50% of cases of MVO." - Anonymous Online Contributor

Unverified Answer

Does temanogrel improve quality of life for those with microvascular obstruction (mvo)?

"These data suggest that the improvement in quality of life following treatment with temanogrel may be associated with the reduction in the rate of heart failure hospital admission in patients with microvascular obstruction." - Anonymous Online Contributor

Unverified Answer

How serious can microvascular obstruction (mvo) be?

"At a rate of 10 percent, the severity of mvo could be as serious as macrovasculopathy. Patients with mvo of less than 50% should undergo further evaluation for their condition to optimize treatment." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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