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The long-term effectiveness, safety and economic evaluation of Guanxinning tablet for coronary artery disease: A multicenter, open label clinical trial

The long-term effectiveness, safety and economic evaluation of Guanxinning tablet for coronary artery disease: A multicenter, open label clinical trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IIR-17010688
Enrollment
Unknown
Registered
2017-02-20
Start date
2017-03-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

coronary artery disease

Interventions

Intervention group:Guanxinning Tablet+conventional treatment
Control group:conventional therapy

Sponsors

Xiyuan Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Patients with stable coronary artery disease who have undergone PCI and have began antiplatelet therapy with aspirin alone for at least 1 month after over 12 months dual antiplatelet therapy ( aspirin plus clopidogrel or ticagrelor; (2) diagnosed as TCM pattern of heart blood stasis; (3) aged between 18 to 80 years old regardless of gender; (4) voluntary to participate and providing written informed consents.

Exclusion criteria

Exclusion criteria: 1. patients with heart failure of NYHA IV; 2. Uncontrolled blood pressure, with a systolic blood pressure =180 mmHg or a diastolic blood pressure=100 mmHg, combined with severe cardiopulmonary insufficiency,severe arrythmia,Severe primary hepatic, renal, hematologic, mental disorders or fatal disease like cancer; 3. high bleeding risk,such as history of hemorrage of vital organs (brain or upper gastrointestinal tract) within 6 months,low platelet counts,abnormal coagulation function,currently taking warfarin,etc.; 4. serum level of ALT,AST or Scr >1.5 times upper limit of normal; 5. Allergic constitution,allergic to multiple food or drugs or allergic to the trial drug; 6. Pregnant, planning to pregnant or lactating women; 7. participating another clinical trial within 1 month.

Design outcomes

Primary

MeasureTime frame
composite major adverse cardiovascular events(cardiovascular death, non-fatal myocardial infarction, stent thrombosis, revascularization, ischemic stroke and rehospitalization due to unstable angina);

Secondary

MeasureTime frame
all-cause mortality;cardiovascular death;non-fatal myocardial infarction;stent thrombosis;revascularization;ischemic stroke;rehospitalization due to unstable angina;nitroglycerin discontinue rate;Seattle Angina Questionnaire;the MOS item short from health survey;cost;

Countries

China

Contacts

Public ContactHao Xu, Rui Gao

Xiyuan Hospital, China Academy of Chinese Medical Sciences

xuhaotcm@hotmail.com+86 18601081161

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 7, 2026