A study to investigate the association between resting heart rate (HR) prognosis of patients with Coronary Artery Disease (CAD) treated with bisoprolol

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-OPN-15007091
• Date of registration: 2015-07-21
• Prospective Registration: No
• Primary sponsor: Cardiovascular Department of Chinese PLA General Hospital
• Public title: A study to investigate the association between resting heart rate (HR) prognosis of patients with Coronary Artery Disease (CAD) treated with bisoprolol
• Scientific title: A study to investigate the association between resting heart rate (HR) prognosis of patients with Coronary Artery Disease (CAD) treated with bisoprolol
• Date of first enrolment: 2011-11-26
• Target sample size: 1:902;
• Recruitment status: Completed
• URL: http://www.chictr.org.cn/showproj.aspx?proj=11472
• Study type: Observational study
• Study design: Non randomized control
• Phase: Post-market

Countries of recruitment

Vietnam

Contacts

• Name: Yundai Chen

• Name: Xinli Fan
• Affiliation: Merck Serono Co., Ltd

Key inclusion & exclusion criteria

Inclusion criteria: 1. Patients aged >=20 years old;
2. CAD patients with stable or unstable angina (UA), accompanied with diabetes or possess >=3 risk factors (Males aged >=55 years or females aged >=65 years, hypertension, dyslipidemia, smoking, CAD family history, obesity);
3. Office resting heart rate >=70 beats/min;
4. Patients who have signed informed consent;
5. Concor was used or prescribed before enrollment.
Exclusion criteria: 1. Patients with contra-indications to Concor? as defined in the insert sheet of Concor:
(1) Acute heart failure or during episodes of heart failure decompention requiring i.v. inotropic therapy;
(2) Cardiogenic shock;
(3) Second or third degree AV block (without a pacemaker);
(4) Sick sinus syndrome;
(5) Sinoatrial block;
(6) Symptomatic bradycardia;
(7) Symptomatic hypotension;
(8) Severe bronchial asthma or chronic obstructive pulmonary diseases;
(9) Severe peripheral arterial occlusive diseases Raynauds syndrome;
(10) Untreated pheochromocytoma;
(11) Metabolic acidosis;
(12) Known allergy to any components of Concor its derivatives.
2. Patients with the following conditions/events:
(1) Acute myocardium infarction (AMI) in the preceding 1 month;
(2) Active myocarditis;
(3) Severe or uncontrolled hypertension (tolic blood pressure [SBP] >180 mm Hg or diastolic blood pressure [DBP] >110 mm Hg);
(4) Severe chronic heart failure (New York Heart Association class III or IV);
(5) Impaired hepatic or renal function (according to local lab standard):
1) Serum alanine aminotransferase (ALT) > twice of the normal valueper limit;
2) Serum Aspartate Aminotransferase (AST) > twice of the normal valueper limit;
3) Serum creatinine > twice of the normal valueper limit;
(6) Other incompatible condition which judged by investigators.
3. Patients who had received the following:
(1) Complete revascularization for a single coronary artery disease confirmed by coronary angiography
(2) Implanted pacemaker or implantable cardioverter defibrillator.
4. Patients who are anticipated to require:
(1) Surgery for valvular disease over the next 3 years;
(2) New addition or doge adjustment of the drugs which can affect heart rate, for example nondihydropyridine Calcium Channel Blockers (CCBs) like verapamil or diltiazem, ivabradine, over the course of the trial.
5. Women of childbearing age without effective contraception measures, or who are pregnant or lactating;
6. Patients unlikely to cooperate in the study or with inability or unwillingness to give informed consent;
7. No legal ability legal ability is limited.

Age minimum: 20
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Coronary Artery Disease

Intervention(s)

1:no;

Primary Outcome(s)

composite cardiac clinical outcomes;heart rate;

Secondary Outcome(s)

echocardiography;carotid artery ultrasound;

Source(s) of Monetary Support

Merck Serono Co., Ltd