If you've had a heart attack and needed a stent, you know the drill: you leave the hospital with a fistful of medications. This study is asking a big question: what if one of those pills could do the job on its own? Doctors are running a pilot study to see if taking just ticagrelor—a powerful blood thinner—is a safe way to prevent more heart trouble after getting a stent for a heart attack (whether it's the kind called NSTEMI or STEMI). They're enrolling 200 people who have the procedure. The main thing they're watching for is a combination of the worst outcomes: death from heart problems, another spontaneous heart attack, or a blood clot forming in the new stent. They'll track everyone for three months. A special safety board is keeping a close eye on the results, especially after the first 50 people finish the study. The goal is to gather initial safety data on this simpler, one-drug strategy. If it proves safe in this pilot, it could pave the way for larger tests to see if it's just as effective as taking multiple drugs, potentially making recovery simpler for patients.
Can a single blood thinner prevent heart attacks after stent placement?
Plain Language Summary
What this means for you:
A pilot study is checking if one blood thinner is safe to prevent complications after a heart attack stent. What this means for you:
A pilot study is checking if one blood thinner is safe to prevent complications after a heart attack stent. View Original Abstract ↓
Status: COMPLETED | Phase: PHASE2
Condition(s): Acute Myocardial Infarction
Intervention(s): Ticagrelor 90mg (DRUG)
A pilot study planned to evaluate initial safety of ticagrelor monotherapy after coronary stenting due to acute myocardial infarction.
The study is a single-centre, single-arm, prospective phase II study 200 patients who undergo coronary artery stenting due to NSTEMI or STEMI will be included.
Primary endpoint (variable):
The composite of cardiac death, spontaneous myocardial infarction or definite or probable stent thrombosis within 3 months.
Detailed: A pilot study with 200 subjects undergoing coronary stenting due to NSTEMI or STEMI.
All patients will undergo invasive coronary angiography and clinically indicated Percutaneous Coronary Intervention (PCI). PCI will be performed using EES and OCT guidance using the MLDMAX algorithm (Morphology, Length, Diameter, Medial dissection, Apposition, Xpansion). Eligibility criteria will be assessed after completion of PCI.
Patients will be given a drug diary to document and as a reminder of the twice daily ticagrelor administration.
The Data Safety Monitoring Board (DSMB) will continuously review the outcomes for these patients. After the first 50 patients have been recruited and at least 30 of these patients have reached 3-month follow-up or had the primary outcome, the DSMB will convene to d
Primary Outcome(s): Major adverse cardiac event
Enrollment: 200 (ACTUAL)
Lead Sponsor: Vastra Gotaland Region
Start: 2021-12-14 | Primary Completion: 2025-06-26