Clinical Trials List
2017-02-01 - 2019-04-30
Phase III
Terminated14
ICD-10I25.2
Old myocardial infarction
ICD-10E11
Type 2 diabetes mellitus
ICD-9412
Old myocardial infarction
A Phase III Multi-Center, Double-Blind, Randomized, Parallel Group, Placebo-Controlled Clinical Trial in High-Risk Type 2 Diabetes Mellitus (T2DM) Subjects With Coronary Artery Disease (CAD) to Determine Whether Bromodomain Extraterminal Domain (BET) Inhibition Treatment With RVX000222 Increases the Time to Major Adverse Cardiovascular Events (MACE)
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Trial Applicant
PROTECH PHARMASERVICES CORPORATION
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Sponsor
Resverlogix Corp.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Chairman/Global PI
Co-Principal Investigator
- Shih-Hsien Sung Division of Cardiovascular Diseases
- Chin-Sung Kuo Division of Endocrinology
- 林幸榮 醫研部
- Kang-Ling Wang 醫院部
- 林怡君 Division of Endocrinology
- Wen-Chung Yu Division of Cardiovascular Diseases
- 黃少嵩 Division of Family Medicine
- Tse-Min Lu Division of Family Medicine
- 吳承學 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
10 Stop recruiting
Audit
CRO
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 林志展 Division of Cardiovascular Diseases
- Ju-Yi Chen Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 郭任遠 Division of Cardiovascular Diseases
- 李應湘 Division of Cardiovascular Diseases
- 簡禎彥 Division of Cardiovascular Surgery
- 蘇正煌 Division of Cardiovascular Diseases
- 李俊偉 Division of Cardiovascular Diseases
- 劉俊傑 Division of Cardiovascular Diseases
- 程崇偉 Division of Cardiovascular Diseases
- 洪大川 Division of Cardiovascular Diseases
- 陳俊延 Division of Cardiovascular Diseases
- 林書毅 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 許榮城 Division of Cardiovascular Diseases
- 邱昱偉 Division of Cardiovascular Diseases
- 莊文博 Division of Cardiovascular Diseases
- 林恆旭 Division of Cardiovascular Diseases
- 廖本智 Division of Cardiovascular Diseases
- 張藝耀 Division of Cardiovascular Diseases
- 杜宗明 Division of Cardiovascular Diseases
- 曾炳憲 Division of Cardiovascular Diseases
- 柯欣榮 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 周銘霆 Division of Cardiovascular Diseases
- 張瑋婷 Division of Cardiovascular Diseases
- 蔣俊彥 Division of Cardiovascular Diseases
- 洪俊聲 Division of Cardiovascular Diseases
- Zhih-Cherng Chen Division of Cardiovascular Diseases
- Chia-Te Liao Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Taiwan National PI
The Actual Total Number of Participants Enrolled
3 Stop recruiting
Audit
None
Co-Principal Investigator
- Yi-Chih Wang Division of Cardiovascular Diseases
- LIAN-YU LIN Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 洪大川 Division of Cardiovascular Diseases
- 陳俊延 Division of Cardiovascular Diseases
- 林書毅 Division of Cardiovascular Diseases
- 蘇正煌 Division of Cardiovascular Diseases
- 李俊偉 Division of Cardiovascular Diseases
- 劉俊傑 Division of Cardiovascular Diseases
- 程崇偉 Division of Cardiovascular Diseases
- 郭任遠 Division of Cardiovascular Diseases
- 李應湘 Division of Cardiovascular Diseases
- 簡禎彥 Division of Cardiovascular Surgery
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Time from randomization to the first occurrence of adjudication-confirmed MACE narrowly
defined as a single composite endpoint of CV Death or Non-fatal MI or Stroke.
Key Secondary Endpoints:
1. Time from randomization to the first occurrence of adjudication-confirmed MACE
broadly defined between treatment groups.
Broadly defined MACE is the occurrence of any of the following events:
CV death
Non-fatal MI
Hospitalization for CVD events which include:
o Unstable angina AND evidence of new or presumed new progressive
obstructive coronary disease, OR
o Emergency revascularization procedures at any time and urgent
revascularization procedures ≥30 days after the index events prior to
randomization
Stroke
2. Time from randomization to CV Death or Non-fatal MI
3. Time from randomization to Non-fatal MI
4. Time from randomization to CV Death
5. Time from randomization to Stroke
6. All-cause mortality
Other Secondary Endpoints:
The percent change in apoA-I, apoB, LDL-C, HDL-C, and TG over time within and
between treatment groups
The change from baseline in HbA1c, fasting glucose, and fasting insulin within
and between treatment groups
Changes in ALP within and between treatment groups for all subjects and
according to quartiles of ALP baseline concentration
Changes from baseline in kidney function in subgroup population with estimated
glomerular filtration rate <60 mL/min/1.7 m2
within and between treatment groups
Exploratory Endpoints:
The percent change in hsCRP, fibrinogen, and inflammatory cytokines within and
between treatment groups
Transcription/mRNA change in whole blood from baseline to 6 weeks treatment
within and between treatment groups
Change in Health Related Quality of Life (HRQOL) as measured using the EQ5D-5L
Inclution Criteria
1. Male and female subjects age 18 and over with documented diagnosed T2DM and a
CAD event not less than 7 days and no more than 90 days prior to Visit 1 (one or more
of the following three primary criteria must be satisfied):
Unstable angina: for a qualifying unstable angina event, each of components (a),
(b), and (c) must be satisfied:
a. Characteristic ischemic pain or discomfort in chest or associated referral areas,
occurring at rest or with minimal exertion
b. ECG changes consistent with acute myocardial ischemia based upon at least
one of the following:
i. new or presumed new ST elevation
ii. new or presumed new ST depression
iii. new or presumed new T-wave inversion
c. Objective evidence of obstructive coronary artery disease based upon at least
one of the following:
i. new or presumed new evidence of myocardial ischemia or infarction by
perfusion imaging
ii. new or presumed new regional wall motion abnormality
iii. current evidence of at least one epicardial coronary artery stenosis ≥70%
by coronary angiography
iv. need for coronary revascularization related to index ACS event
History of percutaneous coronary intervention (PCI) with or without coronary
stenting to treat acute coronary syndrome 7-90 days before Visit 1
Previous MI 7-90 days before screening. Two of the following three criteria
must be satisfied:
a. Characteristic ischemic chest pain or pain in associated referral areas
b. Elevation of troponin T or I or CKMB, if troponin T or I is unavailable at the
local lab (at least above the upper limit of normal for the laboratory)
c. Development of new Q-waves in at least two adjacent electrocardiogram
(ECG) leads or development of a new dominant R wave in V1
2. Documented diagnosis of T2DM (one or more of the following criteria must be met):
Documented history of T2DM
History of taking diabetes medication
HbA1c ≥6.5% at Visit 1
3. For males HDL-C of <40 mg/dL (1.04 mmol/L) and for females HDL-C of <45 mg/dL
(1.17 mmol/L) at Visit 1.
4. In the opinion of the Investigator, subjects currently not on high intensity statin therapy
will be able to start rosuvastatin according to the protocol at Visit 1.
5. In the opinion of the Investigator, subjects currently on statin therapy other than
atorvastatin or rosuvastatin can be switched to rosuvastatin according to the protocol at
Visit 1. High intensity statin therapy doses should remain unchanged during the study
period if at all possible.
6. Female subjects must meet one of the following:
If of childbearing potential, female subjects must have a negative urine pregnancy
test and be willing and able to use medically acceptable non-hormonal method of
birth control (non-hormonal intrauterine device, condom, or diaphragm) or remain
abstinent from Screening until Follow-up Visit.
Be of non-child-bearing potential: post-surgical sterilization or post-menopausal.
7. Have given signed informed consent to participate in this study.
Exclusion Criteria
1. Heart disease which, in the opinion of the investigator, will within 90 days of Visit 1
likely require coronary bypass, PCI, cardiac transplantation, surgical repair and/or
replacement.
2. Previous or current diagnosis of severe heart failure (New York Heart Association
Class IV) or a documented left ventricular ejection fraction (LVEF) of <25% as
determined by contrast left ventriculography, radionuclide ventriculography or
echocardiography. The absence of a LVEF measurement in a subject without a
previous or current diagnosis of heart failure does not prohibit entry into the study.
3. Subjects with evidence of cardiac electrophysiologic instability including a history of
uncontrolled ventricular arrhythmias, uncontrolled atrial fibrillation/flutter or uncontrolled
supraventricular tachycardias with a ventricular response heart rate of >100 beats per
minute at rest within 4 weeks prior to Visit 1.
4. Coronary artery bypass grafting (CABG) within 90 days prior to Visit 1.
5. Evidence of severe renal impairment as determined by any one of the following:
an eGFR <30 mL/min/1.7m2
at Visit 1
a current need for dialysis
6. Uncontrolled hypertension defined as 2 consecutive measurements of sitting blood
pressure of systolic >180 mm Hg or diastolic >100 mm Hg at Visit 1.
7. Current or recent (within 12 months prior to Visit 1) treatment with
immunosuppressants (e.g., cyclosporine).
8. Use of fibrates at any dose or niacin/nicotinic acid 250 mg or more within 30 days prior
to Visit 1.
9. A known allergy or sensitivity to any ingredient in the investigational medicinal product.
10. History of intolerance to atorvastatin or rosuvastatin.
11. Triglycerides >400 mg/dL (4.52 mmol/L) at Visit 1.
12. Any medical or surgical condition which might significantly alter the absorption,
distribution, metabolism or excretion of medication including, but not limited to any of
the following: untreated or incompletely treated thyroid dysfunction, cholecystitis,
Crohn’s disease, ulcerative colitis, or any gastric bypass alteration.
13. Evidence of cirrhosis from liver imaging or biopsy, a history of hepatic
encephalopathy, esophageal or gastric varices, active hepatitis, or prior porta-caval
shunt procedure, or a Child-Pugh score of at least 5 points.
Any one of the following liver enzymes that is >1.5x the upper limit of normal
range (ULN) by central lab at Visit 1
a. Alanine aminotransferase (ALT)
b. Aspartate aminotransferase (AST)
14. A total bilirubin that is >ULN by central lab at Visit 1.
15. History of malignancy of any organ system, treated or untreated, within the past 2
years whether or not there is evidence of local recurrence or metastases, with the
exception of localized basal cell carcinoma of the skin.
16. History or evidence of drug or alcohol abuse within 12 months of Visit 1, in the opinion
of the investigator.
17. Female subjects who are pregnant.
18. Any condition which, in the opinion of the investigator, may place the subject at higher
risk from his/her participation in the study, or is likely to prevent the subject from
complying with the requirements of the study or completing the study.
19. Use of other investigational drugs and devices within 30 days or 5 half-lives of Visit 1,
whichever is longer.
20. History of noncompliance with medical regimens or unwillingness to comply with the
study protocol.
21. Any condition that, in the opinion of the investigator, would confound the evaluation
and interpretation of efficacy and/or safety data.
22. Persons directly involved in the execution of this protocol.
The Estimated Number of Participants
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Taiwan
120 participants
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Global
2400 participants
