A study to investigate the effect of a drug to treat Angina pectoris

Conditions: Stable Angina Pectoris
MedDRA version: 15.0Level: LLTClassification code 10049194Term: Stable angina pectorisSystem Organ Class: 10007541 - Cardiac disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2012-001584-77-DE

Lead Sponsor: Menarini International Operations Luxembourg S.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.

1.Male and female patients (females of childbearing potential must have a negative urine pregnancy test and must be using adequate contraceptive precautions, see also section 17.4)

2.Performed coronary angiography with or without initial PCI more than 24 hours before MRI

3.Remaining = 70% stenosis of a coronary artery bigger than 2 mm diameter (not corrected by PCI)

4.Indication of further interventional treatment

5.Wall motion abnormalities in at least one segment; if segment 17 is affected, an additional segment has to show wall motion abnormalities (for the segment-model, see section 13.3.3)

6.History of chronic angina pectoris

7.Age = 18 years

8.Normalized blood pressure < 140/90 mmHg and heart rate < 70 bpm and = 50 bpm at rest

9.Sinus rhythm

10.Standard therapy: beta-blocker and/or calcium channel blocker (stable for 4 weeks)

11.Signed informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Subjects who meet any of the following exclusion criteria are not enrolled in this study:

1.Cardiac instability, e.g. acute coronary syndrome as indication for the coronary angiography (ST-elevation or positive troponin testing)

2.Contraindication for MRI (e.g. implanted pace maker, internal defibrillator, MRI incompatible devices or metals)

3.Contraindication for dobutamine, atropine, gadolinium based contrast agent, or metoprolol

4.Patients with heart failure classification NYHA III and NYHA IV

5.Myocardial infarction during the last 3 days prior to treatment with ranolazine

6.Severe renal impairment (GFR < 30 ml/min)

7.Moderate or severe hepatic impairment (ALT or AST > 2.5× upper normal limit)

8.Allergic asthma bronchiale

9.Hyperthyroidism or Hashimoto thyreoiditis

10.Myocarditis or inflammatory heart disease

11.Hypertrophic obstructive cardiomyopathy

12.Concomitant administration of class Ia (e.g. quinidine) or class III (e.g. dofetilide, sotalol) antiarrhythmics, except for amiodarone

13.Long acting nitrates

14.Concomitant treatment with potent inhibitors of CYP3A (see also section 11.4)

15.Concomitant treatment with CYP3A inducers (see also section 11.4)

16.Dronedarone

17.Use of greater than 1000 mg daily dose of metformin during the study

18.Hypersensitivity to the active substance or to any of the excipients

19.Hypersensitivity to dobutamine, atropine, gadolinium based contrast agent, or metoprolol

20.Concomitant administration of > 20 mg simvastatin/day

21.History of ECG abnormalities that, in the opinion of the investigator, render the patient unsuitable for the trial, e.g. history of long QT syndrome or significant prolonged QT interval (> 120%)

22.Participation in another trial of an investigational drug or device within 30 days prior to screening

23.Pregnant and breast-feeding women (females of childbearing potential or within two years from the menopause must have a negative urine pregnancy test)

24.Less than 3 months since delivery, abortion, or lactation before the first screening/examination visit

25.Severe psychiatric disorders/neurological disorders

26.Suspected abuse of alcohol, analgesics or psychotropic drugs

27.Disabling or terminal illness

28.Inability or unwillingness to issue the informed consent