A Phase 3, Multicenter, Open Label Study to Confirm the Diagnostic Potential of Intravenously Administered 15O- H2O to Identify Coronary Artery Disease During Pharmacological Stress and Resting Conditions Using PET Imaging

Overview

Sponsor-declared trial summary

Key facts

Sponsor

MedTrace Pharma A/S

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

4 May 2022 → ongoing

Decision date (initial)

2023-05-09

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2023-503843-33-00

EudraCT number

2021-006295-17

ClinicalTrials.gov

NCT05134012

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

Determine the sensitivity and specificity of the 15O-H2O positron
emission tomography (PET) myocardial perfusion imaging (MPI) to
detect coronary artery disease (CAD) using the truth-standard of
invasive coronary angiogram (ICA) with fractional flow reserve (FFR) or
instantaneous wave-Free Ration (iFR) coronary computed tomography
angiogram (CCTA).

Secondary objectives 1

1. 1) Determine the sensitivity and specificity of 15O-H2O PET MPI in subjects of special clinical interest (female, BMI≥30, and diabetics). 2) Evaluation of the safety of 15O-H2O during PET MPI.

Conditions and MedDRA coding

Coronary Artery Disease

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Male and female subjects ≥18 years;
2. Informed consent form (ICF) read, signed, and dated prior to any study procedures being performed;
3. Subjects who fall into any one of the following categories: a. Have been referred for an ICA directly or after non-invasive testing (e.g., SPECT or PET MPI, stress echo, CCTA, ETT). b. Had an ICA with no intervention. However, if any stenosis ≥40% but ≤70% was observed, an FFR or iFR assessment must have been performed. c. Had a CCTA with normal coronaries or minimal CAD (< 25% stenosis).
4. Women of Child Bearing Potential (WOCBP) must be non-pregnant, and non-lactating. For women of childbearing potential, the results of a urine human chorionic gonadotropin (HCG) pregnancy test (with the result known prior to drug administration) must be negative; these subjects must be practicing appropriate birth control from time of the screening until end of the follow-up period. For women who are either surgically sterile (have a documented bilateral tubal ligation or oophorectomy and/or hysterectomy) or are post-menopausal (cessation of menses for more than 1 year), enrollment in the study without a pregnancy test at screening is allowed.
5. Male study subjects must use contraceptive methods until end of the follow-up period.
6. Subjects are able to comply with all study procedures as described in the protocol.

Exclusion criteria 9

1. Subjects are unable to undergo (even partially) any of the imaging procedures;
2. Subjects scheduled for, or planning to undergo, any interventional cardiac procedures between enrollment and ICA (pathway 1) or signing of informed consent and 15O-H2O PET MPI (pathway 2 and 3)
3. Subjects with a known history of cardiac disease including: a. myocardial infarction, previous coronary revascularization, or chronic ischemic cardiomyopathy b. primary myocardial disease such as cardiac amyloidosis or hypertrophic cardiomyopathy c. known left ventricular dysfunction d. moderate or severe aortic or mitral stenosis or regurgitation
4. Subjects in whom adenosine stress testing is contraindicated, including but not limited to: a. Subjects with severe COPD or chronic asthma. b. Subjects with second- or third-degree atrioventricular block without a pacemaker.
5. Subjects with claustrophobia to an extent that would limit their ability to undergo PET imaging (subjects whose claustrophobia is known to be readily controlled with drugs or psychological support may be enrolled).
6. Subjects who are on sildenafil (Viagra), oral dipyridamole (Persantine, Aggrenox) therapy or subjects on any PDE5 inhibitor (i.e. tadalafil, avanafil, vardenafil), and for whom its use cannot be terminated or suspended for at least 5 half-lives prior to treatment of study drug..
7. Subjects with significant co-morbidities that would prevent appropriate completion of the protocol procedures.
8. Subjects who have participated in another research study using investigational drugs within the 30 days prior to enrollment or through the duration of the trial (subjects in observational studies with approved agents and subjects known to be on placebo may be enrolled).
9. Subjects who have previously participated in this study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary efficacy endpoints of the study are the sensitivity and specificity of 15O-H2O Injection PET MPI in the detection of significant CAD. The truth standard used in this study is the presence of clinically significant CAD as assessed by either ICA, ICA with FFR or CCTA.

Secondary endpoints 1

1. None

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

MedTrace Pharma A/S

Sponsor organisation

MedTrace Pharma A/S

Address

Agern Alle 5a

City

Hoersholm

Postcode

2970

Country

Denmark

Scientific contact point

Organisation

MedTrace Pharma A/S

Contact name

Sandra Miran

Public contact point

Organisation

MedTrace Pharma A/S

Contact name

Sandra Miran

Third parties 1

Locations

4 EU/EEA countries · 6 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 25 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

18 submissions — initial application plus substantial / non-substantial modifications