22/10/2023
Improved health after a year
The China Tongxinluo Study for Myocardial Protection in Patients with Acute Myocardial Infarction (CTS-AMI) was a randomized clinical trial conducted in 124 clinical centers throughout China. The Tongxinluo group had 1,899 people, and the placebo group had 1,898 subjects, although some were eventually excluded from the study.
To direct their research, the study’s authors asked: “Among patients with acute ST-segment elevation myocardial infarction (STEMI), does the addition of a traditional Chinese medicine compound (Tongxinluo) as an adjunctive treatment to guideline-directed therapies improve clinical outcomes?”
The researchers administered Tongxinluo orally via capsules to the participants for 12 months, and they gave a placebo to a control group.
The researchers assessed the capsules for clinical effectiveness and safety at 30 days and at one year. Both types of capsules looked, smelled, and tasted the same.
Both groups demonstrated similar patient baseline characteristics and care details. The average age of participants was 61 years, and 77% were male.
The trial ran from May 2019 to December 2020.
Endpoints at 30 days included major adverse cardiovascular and cerebrovascular events (MACCEs) such as cardiovascular death, myocardial re-infarction, cerebral stroke, cardiogenic shock, and heart failure.
One-year endpoints included MACCE, hospitalization due to heart failure, in-stent thrombosis, major bleeding, and all-cause mortality.
The primary endpoint of 30-day major adverse cardiac and cerebrovascular events (MACCEs) dropped substantially with Tongxinluo. Fewer cardiac deaths resulted as well.
Further, these effects carried on throughout one year with no significant change in major bleeding.