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The clinical efficiency and drug economics evaluation research of JIENING asprin enteric tablets

The clinical research of JIENING asprin enteric tablets

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800018517
Enrollment
Unknown
Registered
2018-09-21
Start date
2016-09-26
Completion date
Unknown
Last updated
2018-09-24

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

Conditions

cardiovascular disease

Interventions

Group 1:JIENING aspirin 50mg/d
Group 2:JIENING aspirin 100mg/d
Group 3:Bay-aspirin 100mg/d

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: For primary prevention: enroll high risk CVD populations who need aspirin treatment, and meet the following criteria: 1. aged at least 60 years, and able to take care of themselves; 2. at least one of the following combined diseases: Hypertension, Diabetes, hyperlipidemia; 3. at least two of the following circumstances: smoking history, obesity(BMI index=28 kg/m2), Family history of early onset cardiovascular disease; 4. on or not on aspirin treatment for the primary prevention of CVD; 5. volunteer for this study with informed consents. For secondary prevention: enroll stable coronary artery disease patients on long-term aspirin treatment, and meet the following criteria: 1. aged at least 60 years, and able to take care of themselves; 2. diagnosed as coronary artery disease, on or not on aspirin treatment for the secondary prevention of CVD; 3. stable patients with previous history of PCI for more than 1 year, on aspirin treatment; 4. volunteer for this study with informed consents.

Exclusion criteria

Exclusion criteria: Exclusion criteria: (1) contra-indictions or allergy to aspirin, high bleeding risk patients, such as those with history of erosive gastritis, peptic ulcer or hemorrhage, intracranial hemorrhage; (2) platelet count less than <80×10^9/L; (3) combined with other NSAIDs or hormones; (4)not suitable for enrollment after clinical evaluation, such as uncontrolled hypertension, malignant tumor or severe renal/liver dysfunction; (5) combined with other antiplatelet drugs, including clopidogrel, cilostazol and ticargrelor, or anticoagulants such as warfarin, dabigatran and rivaroxaban; (6) stenosis in left main coronary artery or severe triple vessel disease; (7) patients with poor compliance; (8) those who drop out during the study.

Design outcomes

Primary

MeasureTime frame
Arachidonic Acids-induced platelet aggregation;

Secondary

MeasureTime frame
Fecal occult blood test;

Countries

China

Contacts

Public ContactLiu Meilin

Department of Geriatric, Peking University First Hospital

13910251863@163.com+86 13910251863

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026