What is the clinical evidence from this study?

Study design: RCT. Population: Acute coronary syndrome in diabetic patients (n=400). Intervention: Ticagrelor monotherapy after 3 months of DAPT vs. Ticagrelor plus aspirin DAPT. Primary outcome: Major adverse cardiovascular events (MACE).

What question did this study set out to answer?

This research aims to determine if switching from dual antiplatelet therapy to ticagrelor monotherapy reduces major adverse cardiovascular events in diabetic patients after PCI.

March 29, 2026BMC Cardiovascular Disorders0 citationsOpen Access

Evaluation of safety and affection of variable duration of dual antiplatelet therapy using aspirin plus ticagrelor after successful percutaneous coronary intervention for diabetic patients with acute coronary syndrome

NINADIA M. IBRAHIM MZM. T. M. Zaki KMKhaled Ahmed Fouad Abdel Magid

Key Result

Ticagrelor monotherapy after 3 months of DAPT reduced bleeding events in diabetic patients with ACS undergoing PCI, with no significant difference in MACE compared to 12 months of DAPT.

Key Points

This research aims to determine if switching from dual antiplatelet therapy to ticagrelor monotherapy reduces major adverse cardiovascular events in diabetic patients after PCI.
Randomized, open-label study design
Included 400 diabetic patients with acute coronary syndrome
Compared ticagrelor monotherapy after 3 months of dual therapy to continued dual therapy for 12 months
Assessed major adverse cardiovascular events and bleeding incidents as primary endpoints
No significant difference in major adverse cardiovascular events between the two groups during 12 months
Ticagrelor monotherapy showed lower overall bleeding events, especially mild bleeding
Hemoglobin levels were significantly higher in the monotherapy group (12.97 g/dl) compared to the dual therapy group (12.6 g/dl)

Study Design

Type

RCT (n=400)

Blinding

Open-label

Randomization

Computer-generated randomization sequence (1:1 ratio)

Multicenter

Structured PICO

Does ticagrelor monotherapy after 3 months of DAPT reduce bleeding events and maintain efficacy compared to 12 months of DAPT in diabetic patients with ACS undergoing PCI?

Population

Diabetic patients with acute coronary syndrome (STEMI or NSTEMI) treated with percutaneous coronary intervention (PCI)

Intervention

Ticagrelor monotherapy (90 mg twice daily) initiated after 3 months of dual antiplatelet therapy (aspirin plus ticagrelor)

Comparator

Continued dual antiplatelet therapy (aspirin 81-100 mg once daily plus ticagrelor 90 mg twice daily) for 12 months

Outcome

Major adverse cardiovascular events (MACE), defined as a composite of cardiac death, recurrent myocardial infarction, ischemic stroke, unstable angina requiring hospitalization, or repeat percutaneous coronary interventioncomposite

In diabetic patients with ACS undergoing PCI, transitioning to ticagrelor monotherapy after 3 months of DAPT significantly reduces bleeding events without increasing the risk of major adverse cardiovascular events at 12 months.

Limitations

Open-label design
No formal a priori sample size or power calculation was performed
Baseline imbalances between the study groups regarding hypercholesterolemia, prior PCI, and chronic kidney disease

Abstract

Atherosclerotic cardiovascular disease (ASCVD) represents the primary cause of morbidity and mortality among cases with diabetes. To determine whether a strategy of ticagrelor monotherapy initiated after 3 months of dual antiplatelet treatment (DAPT) modifies the rate of major adverse cardiovascular effect (MACE) as the primary endpoint and bleeding events as the secondary endpoint, relative to a 12-month regimen of ticagrelor-based DAPT in diabetic cases with acute coronary syndrome (ACS) treated by Percutaneous coronary intervention (PCI). This randomized, open-label study included 400 diabetic patients with acute coronary syndrome (STEMI or NSTEMI) treated with PCI. Patients were randomly assigned to receive ticagrelor monotherapy after 3 months of DAPT or to continue ticagrelor plus aspirin for 12 months. The primary endpoint was major adverse cardiovascular events (MACE), and the secondary endpoint was bleeding events. Hemoglobin level after three month was substantially higher in group 1, the mean ± SD was 12.97 ± 1.7 g/dl while group 2 was 12.6 ± 1.47 g/dl (p = 0.02). Platelet count did not differ markedly between groups. Similarly, the incidence of complications—mortality, chest pain, bleeding, ICH, ischemic stroke, recurrent MI, and repeated PCI—showed no significant variation between them. There was no significant difference in the incidence of MACE between the two groups during 12 months of follow-up. Ticagrelor monotherapy was associated with a lower incidence of overall bleeding events, mainly driven by reductions in mild bleeding, while rates of moderate or severe bleeding were comparable between groups. Switching to ticagrelor monotherapy after 3 months of DAPT results in a significant reduction in bleeding events among diabetic cases with ACS undergoing PCI, while maintaining a comparable safety profile regarding complications. Pan African Clinical Trials Registry (PACTR202511832264697) Date of registration 24 November 2025.

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