Precision medicine with zibotentan in microvascular angina (PRIZE)

Phase 1

• Conditions: Microvascular Angina and impaired exercise intolerance.; MedDRA version: 20.0Level: LLTClassification code 10065566Term: Microvascular anginaSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2018-004393-10-GB
• Lead Sponsor: HS Greater Glasgow & Clyde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-07
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 356

Inclusion Criteria

1.Age =>18 years.

2.Microvascular angina1.

3.Able to comply with study procedures.

4.Written informed consent.

FOR OPTIONAL MRI SUB-STUDY

1.Participation in the main study.

2.Able to comply with the sub-study procedures

3.Written informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 178
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 178

Exclusion Criteria

1.Exercise tolerance >540 seconds in men and >430 seconds in women (i.e. actual exercise duration (s) achieved on the Bruce protocol commensurate with predicted), or, lack of anginal symptoms and/or ST-segment depression (0.1 mV) limiting exercise.

2.Non-cardiovascular exercise-limiting problem e.g. morbid (or severe) obesity (BMI =40.0 kg/m2)

3.Endothelin genotype not available

4.Women who are pregnant, breast-feeding or of child-bearing potential (WoCBP) without a negative pregnancy test and who are unwilling or unable to follow the reproductive restrictions defined in section 8.10 (of the study protocol) and use highly effective contraception as defined in Appendix 3 for the duration of the study treatment and 30 days after last dose of study drug.

5.Men who are sexually active with a WoCBP who are unwilling to use condoms or other highly effective methods of contraception for the duration of study treatment and for 14 weeks after last dose of study drug.

6.Heart failure (New York Heart Association Grade =II i.e. mild symptoms and slight limitation during ordinary activity)

7.Recent (<3 months) myocardial infarction

8.A history of epilepsy, other CNS adverse events, neurologic symptoms or signs consistent with spinal cord compression or CNS metastases.

9.Moderate or more severe renal impairment (GFR < 45 mL/min)

10.Liver disease with a Child-Pugh score of A (5-6 points) or higher [41]

11.Participation in another intervention study involving a drug within the past 90 days or 5 half-lives whichever is longer (co-enrolment in observational studies is permitted).

FOR OPTIONAL MRI SUB-STUDY

1.Implantable cardiac device i.e. pacemaker, implantable defibrillator.

2.Contra-indication to intravenous adenosine, i.e. asthma; chronic obstructive lung disease; decompensated heart failure; long QT syndrome; second- or third-degree AV block and sick sinus syndrome; severe hypotension.

3.Contra-indication to contrast media

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified