NCT02227368: TI-PAD EVR

Walking Effect of Long Term Ticagrelor in Subjects With PAD Who Have Undergone EVR

Terminated Phase 2 Results posted Last updated 19 July 2017

What this trial tests

Phase 2 trial testing Ticagrelor in Peripheral Artery Disease (PAD) in 40 participants. Terminated before completion.

Timeline

20 October 2014

Primary endpoint
23 May 2016

23 May 2016

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	40
Start date	20 October 2014
Primary completion	23 May 2016
Estimated completion	23 May 2016
Sites	10 locations across United States

Drugs / interventions tested

• Ticagrelor (ticagrelor) — full drug profile →
• Comparator

Conditions studied

• Peripheral Artery Disease (PAD) — all drugs for Peripheral Artery Disease (PAD) →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 50 to 130, any sex, with Peripheral Artery Disease (PAD). Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Log Transformed Peak Walking Time (PWT) at Week 26 or Early Termination (ET) Primary · 26 Weeks

Group	Value	95% CI
Ticagrelor	0.0	-0.2 – 0.2
Aspirin	0.1	-0.0 – 0.3

Change From Baseline in Log Transformed Claudication Onset Time (COT) at Week 26 or Early Termination (ET) Secondary · 26 Weeks

Group	Value	95% CI
Ticagrelor	0.6	0.1 – 1.1
Aspirin	0.5	0.1 – 0.8

Adverse events — posted to ClinicalTrials.gov

Time frame: 26 weeks treatment period + 30 days followup. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Ticagrelor

Serious: 4/16 (25%)

Deaths: —

Aspirin

Serious: 2/24 (8%)

Deaths: —

Serious adverse events (8 terms)

Reaction	System	Ticagrelor	Aspirin
Coronary artery disease	Cardiac disorders	—	—
Cellulitis	Infections and infestations	—	—
Osteomyelitis	Infections and infestations	—	—
Syncope	Nervous system disorders	—	—
Skin ulcer	Skin and subcutaneous tissue disorders	—	—
Haemorrhage	Vascular disorders	—	—
Hypotension	Vascular disorders	—	—
Peripheral artery stenosis	Vascular disorders	—	—

Other adverse events (2 terms — click to expand)

Reaction	System	Ticagrelor	Aspirin
Procedural haemorrhage	Injury, poisoning and procedural complications	—	—
Arterial occlusive disease	Vascular disorders	—	—

Most-reported serious reactions: Coronary artery disease, Cellulitis, Osteomyelitis, Syncope, Skin ulcer, Haemorrhage, Hypotension, Peripheral artery stenosis.

Data from ClinicalTrials.gov NCT02227368 adverse events section.

Sponsor's own description

To compare the effect of ticagrelor versus aspirin on the change in peak walking time, evaluated on the graded treadmill test, from one to 26 weeks post-revascularization in patients with peripheral artery disease who have undergone endovascular revascularization for moderate to severe claudication or ischemic rest pain.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Ticagrelor in Peripheral Artery Disease Endovascular Revascularization (TI-PAD): Challenges in clinical trial execution.
   Rogers RK, Hiatt WR, Patel MR, Shishehbor MH, et al · · 2018 · cited 2× · PMID 29629845 · DOI 10.1177/1358863x18760996